insulin from bovine pancreas
insulin from bovine pancreas
CAS: 11070-73-8
Molecular Formula: C254H377N65O75S6
insulin from bovine pancreas - Names and Identifiers
| Name | insulin from bovine pancreas |
| Synonyms | insulin human insulin bovine INSULIN BOVINE Insulin (bovin) insulin bovine usp INSULIN, BOVINE, SODIUM Recombinant human insulin Insulin from bovine pancreas insulin from bovine pancreas Human insulin,recombiannt from E.coli insulin hybri-max from bovine pancreas INSULIN, BOVINE SOLUTION CELL CULTURE*TE INSULIN FROM BOVINE PANCREAS*CELL CULTUR E TESTED INSULIN FROM BOVINE PANCREAS GAMMA-*IRRA DIATED CELL |
| CAS | 11070-73-8 |
| EINECS | 234-291-2 |
| InChI | InChI=1/C254H377N65O75S6/c1-29-131(24)205(312-192(334)103-256)250(389)317-204(130(22)23)246(385)287-158(74-81-199(344)345)216(355)281-155(70-77-188(260)330)220(359)307-183-116-399-400-117-184-242(381)305-177(110-321)238(377)293-161(87-122(6)7)223(362)294-167(94-139-52-60-145(324)61-53-139)226(365)282-153(68-75-186(258)328)217(356)289-160(86-121(4)5)221(360)284-157(73-80-198(342)343)219(358)301-173(100-189(261)331)233(372)297-169(96-141-56-64-147(326)65-57-141)229(368)308-182(241(380)303-175(253(393)394)102-191(263)333)115-398-396-113-180(212(351)270-106-193(335)277-152(71-78-196(338)339)215(354)280-150(50-41-83-268-254(264)265)210(349)269-107-194(336)278-165(92-137-45-35-31-36-46-137)225(364)296-166(93-138-47-37-32-38-48-138)228(367)298-170(97-142-58-66-148(327)67-59-142)236(375)318-206(135(28)323)251(390)319-84-42-51-185(319)244(383)285-151(49-39-40-82-255)213(352)276-134(27)252(391)392)310-248(387)202(128(18)19)315-234(373)163(89-124(10)11)291-227(366)168(95-140-54-62-146(325)63-55-140)295-222(361)159(85-120(2)3)288-207(346)132(25)274-214(353)156(72-79-197(340)341)286-245(384)201(127(16)17)314-235(374)164(90-125(12)13)292-231(370)172(99-144-105-267-119-273-144)300-237(376)176(109-320)279-195(337)108-271-211(350)179(112-395-397-114-181(309-243(183)382)240(379)275-133(26)208(347)304-178(111-322)239(378)316-203(129(20)21)249(388)311-184)306-224(363)162(88-123(8)9)290-230(369)171(98-143-104-266-118-272-143)299-218(357)154(69-76-187(259)329)283-232(371)174(101-190(262)332)302-247(386)200(126(14)15)313-209(348)149(257)91-136-43-33-30-34-44-136/h30-38,43-48,52-67,104-105,118-135,149-185,200-206,320-327H,29,39-42,49-51,68-103,106-117,255-257H2,1-28H3,(H2,258,328)(H2,259,329)(H2,260,330)(H2,261,331)(H2,262,332)(H2,263,333)(H,266,272)(H,267,273)(H,269,349)(H,270,351)(H,271,350)(H,274,353)(H,275,379)(H,276,352)(H,277,335)(H,278,336)(H,279,337)(H,280,354)(H,281,355)(H,282,365)(H,283,371)(H,284,360)(H,285,383)(H,286,384)(H,287,385)(H,288,346)(H,289,356)(H,290,369)(H,291,366)(H,292,370)(H,293,377)(H,294,362)(H,295,361)(H,296,364)(H,297,372)(H,298,367)(H,299,357)(H,300,376)(H,301,358)(H,302,386)(H,303,380)(H,304,347)(H,305,381)(H,306,363)(H,307,359)(H,308,368)(H,309,382)(H,310,387)(H,311,388)(H,312,334)(H,313,348)(H,314,374)(H,315,373)(H,316,378)(H,317,389)(H,318,375)(H,338,339)(H,340,341)(H,342,343)(H,344,345)(H,391,392)(H,393,394)(H4,264,265,268)/t131-,132-,133-,134-,135?,149-,150-,151-,152-,153-,154-,155-,156-,157-,158-,159-,160-,161-,162-,163-,164-,165-,166-,167-,168-,169-,170-,171-,172-,173-,174-,175-,176-,177-,178-,179-,180-,181-,182-,183-,184-,185-,200-,201-,202-,203-,204-,205-,206-/m0/s1 |
insulin from bovine pancreas - Physico-chemical Properties
| Molecular Formula | C254H377N65O75S6 |
| Molar Mass | 5733.49 |
| Solubility | acidified water, pH2.0: 2mg/mL |
| Appearance | solution |
| Merck | 13,5003 |
| Storage Condition | -20°C |
| Stability | Stable. Incompatible with strong oxidizing agents. Keep refrigerated at -20 C |
| MDL | MFCD00131380 |
insulin from bovine pancreas - Risk and Safety
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | NM8900250 |
| FLUKA BRAND F CODES | 3-10 |
insulin from bovine pancreas - Reference
| Reference Show more | 1. Zhang Jingwei, Yao Yingjun, Liang Yuan, etc Effect of oleic acid on adipogenic differentiation of C57/BL6J mouse adipose stem cells in vitro [J] Journal of Dalian University of Technology, 2017 (5). 2. Luo Mingzhi, Yu Peili, Jin Yang, etc Effects of sanguinarine on biomechanical properties of airway smooth muscle cells in rats [J] Journal of Biomedical Engineering, 2018, v.35 (04): 89-97. 3. Pang Yan, Lu Jianqi, Zhu Zhide, Wang Qinggao, Wen Zhihao, Liang Yiqiang, Lin Hao, Tang Meiling, Xu Zhiliang. Effect of Wenxin Granule on myocardial steatosis and E6AP, C/EBP in rats with myocardial infarction α Expression effect [J]. Chinese Journal of basic medicine of traditional Chinese medicine, 2021, 27 (01): 61-64. < br > 4. Hu et al. Hui, Wang Xiuli, Ren Leilei. Preparation and detection of insulin super porous hydrogel controlled release preparation [J]. Journal of pharmaceutical practice, 2021, 39 (01): 44-48 + 76. < br > 5. Li Siwei, Wei Qianqian, song Xiao, Zhang Heng, Jiao Yunping. Study on antioxidant and hypoglycemic activities of Codonopsis pilosula polysaccharide [J]. Clinical medical research and practice, 2020, 5 (32): 8-11 6. Wu, Mingxin, et al. "Assisted 3D printing of microneedle patches for minimally invasive glucose control in diabetes." Materials Science and Engineering: C 117 (2020): 111299.https://doi.org/10.1016/j.msec.2020.111299 7. Zhang, Yujie, et al. "Glucose-Responsive Gold Nanocluster-Loaded Microneedle Patch for Type 1 Diabetes Therapy." ACS Applied Bio Materials 3.12 (2020): 8640-8649.https://doi.org/10.1021/acsabm.0c01042 8. [IF=10.618] Xiuhua Sun et al."Creation of antifouling microarrays by photopolymerization of zwitterionic compounds for protein assay and cell patterning."Biosens Bioelectron. 2018 Apr;102:63 9. [IF=7.79] Yujie Zhang et al."Gold nanoclusters for controlled insulin release and glucose regulation in diabetes."Nanoscale. 2019 Mar;11(13):6471-6479 10. [IF=6.953] Meirong Bai et al."Regulated basal and bolus insulin release from glucose-responsive core-shell microspheres based on concanavalin A-sugar affinity."Int J Biol Macromol. 2018 Jul;113:889 11. [IF=6.057] Shaoai Sun et al."Preparation and retention mechanism exploration of mesostructured cellular foam silica as stationary phase for high performance liquid chromatography."Talanta. 2016 Mar;149:187 12. [IF=5.88] Ruixue Yin et al."Engineering synthetic artificial pancreas using chitosan hydrogels integrated with glucose-responsive microspheres for insulin delivery."Mat Sci Eng C-Mater. 2019 Mar;96:374 13. [IF=4.079] Rong-zu Nie et al."A-type dimeric epigallocatechin-3-gallate (EGCG) is a more potent inhibitor against the formation of insulin amyloid fibril than EGCG monomer."Biochimie. 2016 Jun;125:204 14. [IF=3.205] Dandan Lan et al."Preparation of a hydroxyethyl-based monolithic column and its application in the isolation of intact proteins from complex bio-samples."J Chromatogr B. 2019 Jan;1104:89 15. [IF=3.04] Z. Chen et al."Impaired learning and memory in rats induced by a high‐fat diet: Involvement with the imbalance of nesfatin‐1 abundance and copine 6 expression."J Neuroendocrinol. 2017 Apr;29(4): 16. [IF=2.932] Jihui Wang et al."Linoelaidic acid enhances adipogenic differentiation in adipose tissue-derived stromal cells through suppression of Wnt/β-catenin signaling pathway in vitro."Prostag Leukotr Ess. 2016 Jul;110:1 17. [IF=2.877] Tao Wu et al."Timing of glucocorticoid administration determines severity of lipid metabolism and behavioral effects in rats."Chronobiol Int. 2017;34(1):78-92 18. [IF=2.509] Farzana Abbasi et al."Effects of feeding corn naturally contaminated with aflatoxin on growth performance, apparent ileal digestibility, serum hormones levels and gene expression of Na+, K+-ATPase in ducklings."Asian Austral J Anim. 2018 Jan; 31(1): 91–97 19. [IF=2.352] Rong-zu Nie et al."Comparison of disaggregative effect of A-type EGCG dimer and EGCG monomer on the preformed bovine insulin amyloid fibrils."Biophys Chem. 2017 Nov;230:1 20. [IF=1.851] Wei Gao et al."Mitochondrial transcription factor A contributes to cisplatin resistance in patients with estrogen receptor‑positive breast cancer."Mol Med Rep. 2016 Dec;14(6):5304-5310 21. [IF=10.435] Zhang Yujie et al."High drug-loading gold nanoclusters for responsive glucose control in type 1 diabetes."J Nanobiotechnol. 2019 Dec;17(1):1-11 22. [IF=7.514] Lu Han et al."Co-delivery of insulin and quercetin in W/O/W double emulsions stabilized by different hydrophilic emulsifiers."Food Chem. 2022 Feb;369:130918 23. [IF=7.514] Chi Zhang et al."Identification of soybean peptides and their effect on the growth and metabolism of Limosilactobacillus reuteri LR08."Food Chem. 2022 Feb;369:130923 24. [IF=7.328] Mingxin Wu et al."Assisted 3D printing of microneedle patches for minimally invasive glucose control in diabetes."Mat Sci Eng C-Mater. 2020 Dec;117:111299 25. [IF=6.868] Zhu Shiming et al."Insulin/IGF signaling and TORC1 promote vitellogenesis via inducing juvenile hormone biosynthesis in the American cockroach."Development. 2020 Oct;147(20): 26. [IF=6.331] Yujie Zhang et al."A dissolving and glucose-responsive insulin-releasing microneedle patch for type 1 diabetes therapy."J Mater Chem B. 2021 Jan;9(3):648-657 27. [IF=4.966] Yifan Wang et al."Intestinal microbiota contributes to altered glucose metabolism in simulated microgravity mouse model."Faseb J. 2019 Sep;33(9):10140-10151 28. [IF=4.36] Pin Gong et al."Hypoglycemic effect of astragaloside IV via modulating gut microbiota and regulating AMPK/SIRT1 and PI3K/AKT pathway."J Ethnopharmacol. 2021 Dec;281:114558 29. [IF=3.665] Zhenyu Xu et al."Microparticles based on alginate/chitosan/casein three-dimensional system for oral insulin delivery."Polym Advan Technol. 2021 Nov;32(11):4352-4361 30. [IF=4.534] Jingwei Zhang et al.Ndufa6 regulates adipogenic differentiation via Scd1.Adipocyte. 2021;10(1):646-657 31. [IF=6.331] Zhaoyang Guo et al."Responsive hydrogel-based microneedle dressing for diabetic wound healing."J Mater Chem B. 2022 Mar;: 32. [IF=4.158] Zhu Shenglong et al."Blockage of NDUFB9-SCD1 pathway inhibits adipogenesis."J Physiol Biochem. 2022 Feb;:1-12 33. [IF=7.514] Lu Han et al."Effects of inducer type and concentration on the formation mechanism of W/O/W double emulsion gels."Food Chem. 2022 Jun;379:132166 34. [IF=8.697] Li-Shan Yan et al."Schisandrin B mitigates hepatic steatosis and promotes fatty acid oxidation by inducing autophagy through AMPK/mTOR signaling pathway."Metabolism. 2022 Apr;:155200 |
insulin from bovine pancreas - Nature
Open Data Verified Data
The molecular structure of human insulin and porcine insulin is very similar, only the amino acid at the 30th position of the B chain is different, the pig is alanine, and the human is threonine. After subcutaneous injection of recombinant human insulin, the inactivation and excretion in vivo were faster than that of purified Porcine insulin. The control of blood glucose is faster than that of animal insulin, and patients who have an allergic reaction to the animal's original insulin have a good response to the recombinant human insulin. The price is more expensive than pig insulin 10%, 1 times more expensive than bovine insulin.
Last Update：2024-01-02 23:10:35
insulin from bovine pancreas - Preparation Method
Open Data Verified Data
There are two ways to produce insulin from E. Coli. One is to synthesize A chain and B chain in E. Coli respectively, and then chemically connect the two peptide chains to form insulin in vitro; another method is to produce Proinsulin, the insulin precursor, and then add the enzyme
.
Insulin. Human Insulin produced with E. Coli, 40mg of insulin can be harvested per L of fermentation broth.
Last Update：2022-01-01 11:12:04
insulin from bovine pancreas - Standard
Authoritative Data Verified Data
- This product is a protein consisting of 51 amino acid residues produced by recombinant technology. The content of recombinant human insulin (including A21 deaminated human insulin) should be 95.0% to 105.0% based on the dry product.
- per 1 unit of recombinant human insulin corresponds to 0.0347mg.
Last Update：2024-01-02 23:10:35
insulin from bovine pancreas - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is almost insoluble in water, ethanol and ether, and is easily soluble in dilute hydrochloric acid and dilute sodium hydroxide solution.
Last Update：2022-01-01 13:42:53
insulin from bovine pancreas - Use
Open Data Verified Data
treatment of diabetes.
Last Update：2022-01-01 11:12:04
insulin from bovine pancreas - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of this product, add 0.1% trifluoroacetic acid solution to dissolve and dilute to make a solution containing 10mg per 1 ml, take 20ul, add 20ul of 0.2mol/L Tris (hydroxymethyl) aminomethyl synthetic-hydrochloric acid buffer (pH 7.3), 20ul of 0.1% V8 enzyme solution and 140ul of water, mix well, place in 37°C water bath for 2 hours, 3ul of phosphoric acid was added as a test solution; An appropriate amount of recombinant human insulin control was additionally taken and prepared by the same method as a control solution. Under the chromatographic conditions of content determination, the mobile phase A was 0.2mol/L sulfate buffer (pH 2.3)-acetonitrile (90:10), and the mobile phase was acetonitrile-water (50:50). For mobile Phase B, gradient elution was performed as follows. 25ul of the reference solution and the test solution were injected into the liquid chromatograph respectively, and the chromatograms were recorded. The peptide map of the test solution should be consistent with the peptide map of the reference solution.
Last Update：2022-01-01 13:42:54
insulin from bovine pancreas - Exam
Authoritative Data Verified Data
Related substances
take an appropriate amount of this product, add 0.01 mol/L hydrochloric acid solution to dissolve and dilute to prepare a solution containing 3.5mg per 1 ml as a test solution. Under the chromatographic conditions of content determination, the mobile phase A was 0.2 mol/L sulfate buffer (pH 2.3)-acetonitrile (82:18), and the mobile phase was acetonitrile-water (50:50). For mobile Phase B, gradient elution was performed as follows. Adjust the mobile phase ratio so that the retention time of the main peak of recombinant human insulin is about 25 minutes, and the system suitability test shall comply with the provisions under The Content determination item. 20ul of the sample solution is injected into the human liquid chromatograph, and the chromatogram is recorded. According to the peak area normalization method, the content of human insulin containing A21 deammoniation shall not be more than 1.5%, and the sum of the peak areas of other impurities shall not be more than 2.0%.
high molecular protein
take an appropriate amount of this product, add 0.Olmol/L hydrochloric acid solution to dissolve and dilute to prepare a solution containing about 4mg per 1 ml as a test solution. Tested according to size exclusion chromatography (General 0514). Hydrophilic modified silica gel was used as filler (5 ~ lOum); Glacial acetic acid-acetonitrile-0.1% arginine solution (15:20:65) was used as mobile phase; Flow rate was 0.5ml per minute; the detection wavelength was 276nm. The recombinant human insulin monomer-dimer control was dissolved and diluted with 0.01mol/L hydrochloric acid solution to make a solution containing about 4mg per 1 ml, the resolution of monomer peak and dimer peak of recombinant human insulin should meet the requirements. Take the test solution of lool, inject human liquid chromatograph, record the chromatogram, subtract the other peak areas whose retention time is greater than the main peak of recombinant human insulin, and calculate according to the peak area normalization method, retention time less than the sum of all peak areas of the main peak of recombinant human insulin should not be greater than 1.0%.
loss on drying
take 0.2g of this product, dry to constant weight at 105°C, and lose no more than 10.0% of weight (General rule 0831).
ignition residue
take about 0.2g of this product, check according to law (General 0841), residue shall not exceed 2.0%.
zinc
precision weighing the appropriate amount of this product, plus 0.Olmol/ L hydrochloric acid solution dissolved and quantitative dilution made of each lml containing about 0.lmg of the solution. Another precise amount of zinc single element standard solution (containing Zn1000ul in each lml) appropriate amount, with 0.01mol/ L hydrochloric acid solution were quantitatively diluted to each lml containing zinc 0.2%, 0.4ug, 0.6ug, 0.8ug, l.Oug with 1.2ug of catalepsy standard solution. According to Atomic Absorption Spectrophotometry (General rule 0406 first method), the absorbance is measured at the wavelength of 213.9nm, and the content of zinc (Zn) shall not be more than 1.0% based on the dry product.
microbial limit
take 0.3g of this product, according to the microbial limit test of non sterile products, microbial count method (General 1105), the total number of aerobic bacteria in lg samples shall not exceed 300cfu.
bacterial endotoxin
take this product, check according to law (General 1143), the amount of endotoxin per 1 mg recombinant human insulin should be less than 10EU.
residual cell protein
take an appropriate amount of this product and check it according to law (General rule 3413). The residual amount of bacterial protein in Recombinant Human Insulin per 1 mg should not exceed 10ng.
residual amount of exogenous DNA
take an appropriate amount of this product and check it according to law (General rule 3408). The host DNA in each dose of recombinant human insulin should not exceed 10ng.
biological activity
take an appropriate amount of this product, according to the insulin bioassay (General rule 1211), the number of experimental animals in each group can be halved, the experiment adopts random design, according to the biological test statistics method (General rule 1431) quantitative reaction parallel line determination of random design method to calculate the titer, the titer of not less than 15 units per lmg.
Last Update：2022-01-01 13:42:55
insulin from bovine pancreas - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with eighteen alkyl silane bonded silica gel as filler (5 ~ 10um); 0.2mol/L sulfate buffer (anhydrous sodium sulfate 28.4g, add water after hydrolysis, add phosphoric acid 2.7ml, water 2.3 ML, adjusted to pH with ethanolamine, water to ML)-acetonitrile (74:26) as mobile phase; Flow rate 1 ml per minute; Column temperature 40°C; Detection wavelength 214mn. Take the system suitable solution (take the recombinant human insulin control, add 0.01mol/L hydrochloric acid solution to dissolve and dilute the solution containing 1 mg per 1 ml, at room temperature for at least 24 hours) 20 u1, note human liquid chromatography, recombinant human insulin peak and A21 deammoniated human insulin peak (relative retention time with recombinant human insulin peak is about 1.3) of the separation is not less than 1.8, tailing factor is not greater than 1.8.
assay
take the right amount of this product, precision weighing, plus O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to make a solution containing 0.35mg (about 10 units) per 1 mL (ready for new preparation). A 20ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. An appropriate amount of reference substance of recombinant human insulin was taken and determined by the same method. According to the external standard method to recombinant human insulin peak and A21 deammoniated human insulin peak area calculation, that is obtained.
Last Update：2022-01-01 13:42:55
insulin from bovine pancreas - Category
Authoritative Data Verified Data
hypoglycemic drugs.
Last Update：2022-01-01 13:42:56
insulin from bovine pancreas - Storage
Authoritative Data Verified Data
light-shielding, hermetically sealed, and stored at a temperature below 15°C.
Last Update：2022-01-01 13:42:56
insulin from bovine pancreas - Recombinant human Insulin lnjection
Authoritative Data Verified Data
- This product is a sterile aqueous solution of recombinant human insulin. The content of recombinant human insulin (C257H383N65O77S6) should be 90.0% to 110.0% of the standard dose.
- This product can be added with appropriate amount of phenol or m-cresol as bacteriostatic agent.
trait
This product is colorless and clear liquid.
identification
- The product was taken, and the same results were shown in the identification (1) Test under the item of recombinant human insulin.
- in the chromatogram recorded under the phenol or m-cresol examination, the retention time of the phenol peak or m-cresol peak in the test solution should be consistent with the retention time of the phenol peak or m-cresol peak in the control solution.
examination
- the pH value should be 6.9 to 0631 (general).
- Related substances take this product, add 9.6mol/L hydrochloric acid solution 3 u1 per 1 ml, as the test solution; take an appropriate amount of the test solution (approximately equivalent to recombinant human insulin 70), test according to the chromatographic conditions under recombinant human insulin, remove the phenol peak or m-cresol peak, and calculate according to the peak area normalization method, the peak of A21 deaminated human insulin shall not be greater than 2.0%; The sum of the peak areas of other impurities shall not be greater than 6.0%.
- high molecular protein take this product, add 9.6mol/L hydrochloric acid solution 3u1 per 1 ml as the test solution; Take 100M1 of the test solution, and check according to the method under recombinant human insulin, excluding other peak areas whose retention time is greater than the main peak of recombinant human insulin, the sum of all peak areas whose retention time is less than the peak of recombinant human insulin shall not be greater than 2.0% calculated by peak area normalization method.
- take an appropriate amount of zinc and dilute it with O.Olmol/L hydrochloric acid solution to prepare a solution containing about 0.4 ~ 0.8ug of zinc per 1 ml as the test solution. According to the method of recombinant human insulin, the content of zinc (Zn) in 3.5mg (equivalent to 100 units) of this product should be 10 ~ 40ug.
- phenol or m-cresol from phenol or m-cresol (purity> 99.5%), Precision weighing, with O.Olmol/L hydrochloric acid solution is diluted quantitatively to make a solution containing about 0.25mg of phenol or m-cresol per 1 ml, which is used as a control solution of phenol or m-cresol, the sample solution was quantitatively diluted with 0.01mol/L hydrochloric acid solution to a solution containing about mg of phenol or m-cresol per 1 ml. The detection wavelength was 270nm under the chromatographic conditions for the determination of recombinant human insulin content. The appropriate amount of recombinant human insulin control was taken and diluted with phenol control solution or m-cresol control solution to prepare a solution containing 1 mg of recombinant human insulin per 1 ml, and 20ul was injected into human liquid chromatograph, the resolution of phenol peak or m-cresol peak from recombinant human insulin peak should meet the requirements. 20 u1 of phenol control solution or m-cresol control solution and test solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded, and the peak area was calculated according to the external standard method. The content of phenol or m-cresol in each 1 ml should be 80.0% to 110.0% of the labeled amount.
- sterile take this product, by membrane filtration method, inspection according to law (General 1101), should comply with the provisions.
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin per unit of recombinant human insulin should be less than 0.80EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision: take an appropriate amount of this product and quantitatively dilute it with 0.0lmol/ L hydrochloric acid solution to make a solution containing 0.35mg(lO units) per lml (ready for use), determined according to the method under recombinant human insulin.
category
Same as recombinant human insulin.
specification
(l ) 3ml:300 units (10.4mg) (2 ) 10ml:400 units (13.9mg)
storage
sealed and stored in cold place to avoid freezing.
Last Update：2022-01-01 13:42:57
insulin from bovine pancreas - Protamine Recombinant Human Insulin Injection
Authoritative Data Verified Data
- This product is a sterile suspension of protamine and recombinant human insulin, containing recombinant human insulin (C257H383N65O77S6) should be 90.0% to 110.0% of the labeled amount.
- This product can add an appropriate amount of phenol or m-cresol as bacteriostatic agent.
trait
This product is white or white suspension, should be able to disperse evenly after shaking. Under the microscope, the crystal is rod-shaped, the vast majority of crystals should not be less than lum, also should not be greater than 60um, no polymer exists.
identification
- add 3ul of 9.6mol/L hydrochloric acid solution per 1 ml to make it completely clear, and the same results were shown according to the identification (1) Test under the item of recombinant human insulin.
- in the chromatogram recorded under the phenol or m-cresol examination, the retention time of the phenol peak or m-cresol peak in the test solution should be consistent with the retention time of the phenol peak or m-cresol peak in the control solution.
examination
- the pH value should be 6.9 to 7.8 (General 0631).
- Related substances take this product and add 3ul of 9.6mol/L hydrochloric acid solution per 1 ml as the test solution. Take appropriate amount of sample solution (equivalent to recombinant human insulin 70ug) to test under the chromatographic condition of recombinant human insulin, remove phenol peak or m-cresol peak and fish sperm protein peak, and calculate according to peak area normalization method, a21 deammoniated human insulin shall not be greater than 2.0%, and the sum of the peak areas of other impurities shall not be greater than 6.0%.
- high molecular protein take this product and add 9.6mol/l hydrochloric acid solution 3u1 per l as the test solution. Take the sample solution for lool, check according to the method under recombinant human insulin item, remove other peak areas with retention time greater than the peak of recombinant human insulin, and calculate according to the peak area normalization method, retention time less than the sum of all peak areas of the recombinant human insulin peak must not be greater than 3.0%.
- take an appropriate amount of zinc and add 9.6mol/L hydrochloric acid solution 3fJ per 1 ml to make it completely clear. An appropriate amount was taken in a precise amount, and quantitatively diluted with O.Olmol/L hydrochloric acid solution to prepare a solution containing about 0.4-0.8ug of zinc per 1 ml as a test solution. The amount of zinc (Zn) contained in each 3.5mg of recombinant human insulin should be 10-40UG as checked under the item of recombinant human insulin.
- recombinant human insulin in the supernatant 10ml of this product, 1500g centrifugation for 10 minutes, take the supernatant, add 3ul of 9.6mol/L hydrochloric acid solution per 1 ml, mix well, as a test solution; an appropriate amount of the recombinant human insulin control solution under the content measurement item was quantitatively diluted with 0.01mol/L hydrochloric acid solution to prepare a solution containing about 50ug per 1 ml as a control solution. The supernatant should not contain more than 2.5% of human insulin, as determined by the method described under the item of recombinant human insulin assay.
- phenol and m-cresol phenol and m-cresol (purity> 99.5%), Precision weighing, with O.Olmol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 0.06mg of phenol and 0.15mg of m-cresol in each lml, which is used as a mixed control solution of phenol and m-cresol, add 3ul of 9.6mol/L hydrochloric acid solution per 1 ml to make it completely clear. Olmol/L hydrochloric acid solution was quantitatively diluted to a solution containing about 0.06mg of phenol or 0.15mg of M-formic acid per 1 ml as a test solution. The detection wavelength was 270nm under the chromatographic conditions for the measurement of the recombinant human insulin content. Take appropriate amount of recombinant human insulin reference substance, add mixed control solution to dissolve and dilute to make solution containing recombinant human insulin lmg per lml, take 20ul injection human liquid chromatograph, phenol peak, the resolution of m-cresol peak and recombinant human insulin peak should meet the requirements. 20ul of the mixed control solution and 20ul of the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded. The peak area was calculated according to the external standard method. The content of phenol or m-cresol in each 1 ml should be 80.0% to 110.0% of the labeled amount.
- sterile take this product, add% sterile ascorbic acid solution, shake to clarify the solution, after the membrane filtration method, according to the law (General Principles 1101), should comply with the provisions.
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin per unit of recombinant human insulin should be less than 0.80EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take this product, add 3ul of 9.6mol/L hydrochloric acid solution per lml to make it completely clear, take appropriate amount of precision, use O.Olmol/L hydrochloric acid solution was diluted to make a solution containing 0.35mg(10 units) per 1 mL (new preparation), and was determined according to the method of recombinant human insulin.
category
Same as recombinant human insulin.
specification
(l)3ml:300 units (10.4mg) (2) 10ml:400 units (13.9mg)
storage
sealed and stored in cold place to avoid freezing.
Last Update：2022-01-01 13:42:58
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Featured ProductsSpot supply
Product Name: Insulin(bovine pancreas) Visit Supplier Webpage Request for quotationCAS: 11070-73-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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