lincomycin standard solution
Lincocin Hydrochloride
CAS: 859-18-7
Molecular Formula: C18H35ClN2O6S
lincomycin standard solution - Names and Identifiers
| Name | Lincocin Hydrochloride |
| Synonyms | U-10149A LINCOMYCIN HCL Lincomycin Hcl Lincocin Hydrochloride LINCOCIN HYDROCHLORIDE lincomycin hydrochloride LINCOMYCIN HYDROCHLORIDE lincomycin standard solution Lincomycin hydrochloride anhydrous N-[2-HYDROXY-1-(3,4,5-TRIHYDROXY-6-METHYLSULFANYL-OXAN-2-YL)-PROPYL]-1-METHYL-4-PROPYL-PYRROLIDINE-2-CARBOXAMIDE methyl 6,8-dideoxy-6-{[(4R)-1-methyl-4-propyl-L-prolyl]amino}-1-thio-D-erythro-alpha-D-galacto-octopyranoside hydrochloride METHYL 6,8-DIDEOXY-6-(1-METHYL-4-PROPYL-2-PYRROLIDINECARBOXAMIDO)-1-THIO-D-ERYTHRO-ALPHA-D-GALACTOOCTOPYRANOSIDE HYDROCHLORIDE ALPHA-METHYL-6,8-DIDEOXY-6-[1-METHYL-4-PROPYL-2-PYRROLIDINECARBOXAMIDO]-1-THIO-D-ERYTHRO-D-GALACTOOCTOPYRANOSIDE HYDROCHLORIDE |
| CAS | 859-18-7 |
| EINECS | 212-726-7 |
| InChI | InChI=1/C18H34N2O6S.ClH/c1-5-6-10-7-11(20(3)8-10)17(25)19-12(9(2)21)16-14(23)13(22)15(24)18(26-16)27-4;/h9-16,18,21-24H,5-8H2,1-4H3,(H,19,25);1H/t9-,10-,11+,12-,13+,14+,15-,16-,18-;/m1./s1 |
| InChIKey | POUMFISTNHIPTI-BOMBIWCESA-N |
lincomycin standard solution - Physico-chemical Properties
| Molecular Formula | C18H35ClN2O6S |
| Molar Mass | 443 |
| Melting Point | 156-158C |
| Boling Point | 646.8°C at 760 mmHg |
| Flash Point | 345°C |
| Water Solubility | Soluble in water. |
| Solubility | H2O: 50mg/mL, clear, colorless |
| Vapor Presure | 1.85E-19mmHg at 25°C |
| Appearance | solid |
| Color | white to white with yellow cast |
| BRN | 4171650 |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| MDL | MFCD00058237 |
| Use | Linamycin is an antibiotic that forms cross-links in the peptide-based transferase cyclic region of 23S rRNA and inhibits bacterial protein synthesis. |
lincomycin standard solution - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| WGK Germany | 2 |
| RTECS | RH6315000 |
| FLUKA BRAND F CODES | 10 |
| HS Code | 29419000 |
lincomycin standard solution - Reference
| Reference Show more | 1. He Pinjing, Guan Dongxing, Wu duo, et al. Inhibitory effect of ammonia nitrogen and lincomycin on anaerobic digestion of organic matter [J]. Journal of Chemical Engineering, 2011(05):1389-1394. 2. Li Zhongling, Zhang Hongyan, Fu Bo, etc. Study on fermentation conditions of butyric acid bacteria MYS66 [J]. China Brewing, 2018, 037(002):75-79. 3. [IF = 6.953] Weijie Lv et al."Structural modulation of gut microbiota." Int J Biol Macromol. Dec 2017; 105:1622 4. [IF = 3.517] Guanghua He et al."Preparation and antibacterial properties of O-carboxymethyl chitosan/lincomycin hydrogels."J Biomat Sci-Polym E. 2016;27(4):370-384 5. [IF=8.742] Zhiyuan Zha et al."Interlayer-modulated polyamide composite membrane for organic solvent nanofiltration."J Membrane Sci. 2022 Apr;647:120306 |
lincomycin standard solution - Standard
Authoritative Data Verified Data
This product is 6-(l-methyl-trans-4-propyl-L-2-pyrrolidinylamino)-l-thio -6,8-dideoxy-D-erythro-a -D-galactopyranoside IV hydrochloride monohydrate. The content of lincomycin (C18H34N2O6S) shall not be less than 82.5% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
lincomycin standard solution - Trait
Authoritative Data Verified Data
- This product is a white crystalline powder; There is a slight or special odor.
- This product is soluble in water or methanol, slightly soluble in ethanol.
Last Update：2022-01-01 15:05:53
lincomycin standard solution - Introduction
Linamycin is an antibiotic that forms cross-links in the peptide-based transferase cyclic region of 23S rRNA and inhibits bacterial protein synthesis.
Last Update：2022-10-16 17:29:22
lincomycin standard solution - Differential diagnosis
Authoritative Data Verified Data
- take the appropriate amount of this product and the reference substance of lincomycin, respectively, and add methanol to make a solution containing about 10 mg per 1 ml, as the test solution and the reference solution; take the appropriate amount of lincomycin reference and clindamycin reference, and add methanol to make a mixed solution containing about 10 mg per 1 ml, which is used as the system applicable solution, and test according to thin layer chromatography (General 0502), 2 u1 of each of the above-mentioned three kinds of solutions are absorbed, respectively, and are placed on the same silica gel G thin layer plate, with ethyl acetate-formic acid (1.5:1) as the developing solvent, and then dried, and the color is developed in iodine vapor. System applicability the solution should show two separate spots; The position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference solution.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of lincomycin reference substance (paste method) (General rule 0402).
- the aqueous solution of this product can identify the reaction of (1) (General rule 0301).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 15:05:54
lincomycin standard solution - Exam
Authoritative Data Verified Data
crystallinity
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
acidity
take this product, add water to make a solution containing O.lg per lml, and determine it according to law (General 0631). The pH value should be 3.0~5.5.
clarity and color of solution
take 5 parts of this product, 2g each, respectively, add 5ml of water to dissolve, and the solution should be clear; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow or yellow-green No. 1 Standard Colorimetric solution (General Principles 0901 first method).
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 4mg of lincomycin per 1 ml as a test solution; Take 1 ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 10 u1 of the test solution and 10 u1 of the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 3 times of the retention time of the main component peak, if there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%) except the lincomycin B peak, the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
lincomycin B
The Peak area of lincomycin B shall not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B as determined by the method under the content determination item.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 3.0% ~ 6.0%.
ignition residue
not more than 0.5% (General rule 0841).
bacterial endotoxin
take this product, check according to law (General 1143), the amount of endotoxin in lincomycin per 1 mg should be less than 0.50EU. (For injection)
Last Update：2022-01-01 15:05:54
lincomycin standard solution - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as filler; 0.05mol/L borax solution (adjusted to pH 85% with 6.1 phosphoric acid solution)-methanol (1:1) as mobile phase; the detection wavelength was 214nm, the retention time of lincomycin peak was about 16 minutes, and the separation degree between lincomycin peak and lincomycin B Peak (relative retention time of lincomycin peak was about 0.4~0.7) should be greater than 2.6. The resolution between lincomycin peak and adjacent impurity peak should meet the requirements.
assay
take an appropriate amount of this product (about 50mg equivalent to lincomycin), precisely weigh it, add mobile phase to dissolve and quantitatively dilute it into a solution containing about 2mg of lincomycin per 1 ml, which is used as a test solution, 10UL was injected into the liquid chromatograph accurately, and the chromatogram was recorded. An appropriate amount of lincomycin reference was taken and determined by the same method. The content of C18H34N206S in the test sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 15:05:55
lincomycin standard solution - Category
Authoritative Data Verified Data
antibiotics.
Last Update：2022-01-01 15:05:55
lincomycin standard solution - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:05:55
lincomycin standard solution - Lincomycin hydrochloride tablets
Authoritative Data Verified Data
This product contains lincomycin hydrochloride according to lincomycin (C18H34N206S) calculation, should be the label amount of 90.0% ~ 110.0%.
trait
This product is white or white-like tablets or sugar-coated tablets; White or white-like after removing the coating.
identification
- take the fine powder of this product, add an appropriate amount of methanol (every 10mg of lincomycin plus methanol 1 ml), shake for 2-3 minutes, stand still, take the supernatant as the test solution, the same results were shown in the test (1) identified under the item of lincomycin hydrochloride.
- 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.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- relevant substances: take an appropriate amount of fine powder of this product, dissolve it with mobile phase and dilute it to make a solution containing about 4mg of lincomycin per 1 ml, filter it, take the continued filtrate, and measure it according to the method under the item of lincomycin, the requirements shall be met.
- The Peak area of lincomycin B shall not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B as determined by the method under the item of content determination.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing take appropriate amount (about equivalent to lincomycin 0.2g ); If it is sugar-coated tablets, take 4 tablets, all ground fine. Add 80% ethanol solution to dissolve and quantitatively dilute to make a solution containing about 10mg of lincomycin per 1 ml, filter, and take appropriate amount of the filtrate with precision, A solution containing about 2mg of lincomycin per 1 ml was prepared by quantitative dilution with the mobile phase, and as a test solution, it was obtained by measuring according to the method under the item of lincomycin hydrochloride.
category
with lincomycin hydrochloride.
specification
Based on C18H34N206S (1)0.25g (2)0.5g
storage
sealed storage.
Last Update：2022-01-01 15:05:56
lincomycin standard solution - Lincomycin Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of lincomycin hydrochloride. Lincomycin-containing (C18H34N206S) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is colorless to yellowish or yellowish green clear liquid.
identification
- take the appropriate amount of this product and lincomycin reference, and add methanol to make a solution containing about 10mg per 1 ml, which is used as the test solution and the reference solution, and identify according to the item of lincomycin hydrochloride (1) the same results were seen in one trial.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- the pH value of this product is obtained by adding water to make a solution containing 0.lg of lincomycin per lml, which is measured according to law (General rule 0631). The pH value should be 3.0~5.5.
- color this product should be colorless, such as color, and yellow or yellow-green No. 2 Standard Colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
- Related Substances: dilute the product with mobile phase to make a solution containing about 4mg of lincomycin per 1 ml, and use it as a test solution. Take 1 ml and place it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, each L01 of the test solution and the control solution is accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%) except the lincomycin B peak, the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
- The Peak area of lincomycin B shall not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B as determined by the method under the item of content determination. The appropriate amount of benzyl alcohol is accurately weighed and the sample solution is prepared according to the method under the item of related substances. The appropriate amount of benzyl alcohol is accurately weighed and diluted quantitatively with mobile phase to make a solution containing about 0.13mg per 1 ml, as a control solution. Determine according to the method under the item of related substances, take each l0ul of the test solution and the control solution, inject the human liquid chromatograph respectively, record the chromatogram, and calculate the peak area according to the external standard method, each lml of this product containing benzyl alcohol should not exceed 9.45mg.
- the bacterial endotoxin should be checked according to the method under the item of lincomycin hydrochloride and be in accordance with the regulations.
- sterile take this product, diluted with appropriate solvent, treated by membrane filtration method, inspection according to law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L borax solution (adjusted to pH 85% with 5.0 phosphoric acid solution)-Methanol-acetonitrile (67:33:2) as mobile phase; The detection wavelength was 214mn. The retention time of lincomycin peak is about 16 minutes, and the separation degree of lincomycin peak and lincomycin B Peak (relative retention time of lincomycin peak is about 0.4~0.7) should not be less than 2.6. The resolution between lincomycin peak and adjacent impurity peak should meet the requirements.
- determination precision: take an appropriate amount of this product, quantitatively dilute it with mobile phase to prepare a solution containing 2mg of lincomycin per 1 ml, shake well, and use it as a test solution, lOul was injected into human liquid chromatograph accurately, and the chromatogram was recorded. The appropriate amount of lincomycin reference substance was taken and determined by the same method. The content of C18H34N2O6S in the sample was calculated by the peak area according to the external standard method.
category
with lincomycin hydrochloride.
specification
Based on C18H34N206S (l ) lml:0.2g(2)lml:0.3g (3) 2ml:0.3g (4) 2ml:0.6g (5)4ml:1.2g (6)10ml:3G
storage
sealed storage.
Last Update：2022-01-01 15:05:57
lincomycin standard solution - Lincomycin hydrochloride capsules
Authoritative Data Verified Data
This product contains lincomycin hydrochloride according to lincomycin (C18H34N206S) calculation, should be the label amount of 90.0% ~ 110.0%.
trait
The content of this product is white or white crystalline powder.
identification
- take an appropriate amount of the contents of this product, add methanol to make a solution containing about 10 mg of lincomycin in each lrnl, shake for 2-3 minutes, stand still, and take the supernatant as the test solution, the same results were shown in the test (1) identified under the item of lincomycin hydrochloride.
- 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.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- relevant substances: Take appropriate amount of the contents of this product, add the mobile phase to dissolve and dilute to make a solution containing about 4mg of lincomycin per 1 ml, filter, take the filtrate, and determine it according to the method under the item of lincomycin, the requirements shall be met. The Peak area of lincomycin B shall not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B.
- moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for moisture determination (General rule 7.0%, Method 1).
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the item of difference in loading amount, mix them evenly, weigh the appropriate amount accurately (about 0.2g equivalent to lincomycin), the mobile phase is added to dissolve and quantitatively dilute to prepare a solution containing about 2mg of lincomycin per 1 ml, filtered, and the filtrate is taken as the test solution, which is obtained by measuring according to the method under the item of lincomycin hydrochloride.
category
with lincomycin hydrochloride.
specification
Based on C18H34N206S (1)0.25g (2)0.5g
storage
sealed storage.
Last Update：2022-01-01 15:05:58
lincomycin standard solution - Lincomycin hydrochloride ear drops
Authoritative Data Verified Data
This product contains lincomycin hydrochloride according to lincomycin (C18H34N2O6S) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- take the appropriate amount of this product and the reference substance of lincomycin, and add methanol to make a solution containing about 10 mg per 1 ml, as the test solution and the reference solution; the same results were shown in the test (1) identified under the item of lincomycin hydrochloride.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 5.0 to 7.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing about 8mg of lincomycin per 1ml, which should be used as a test solution; 1ml should be accurately measured and placed in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution.
- 1ml of a control solution was quantitatively diluted with a mobile phase to prepare a solution containing about 4ug of lincomycin per 1ml as a sensitivity solution. According to the chromatographic conditions under the content determination item, the sensitivity solution L01 is injected into the liquid chromatograph, and the signal-to-noise ratio of the main component peak height should be greater than 10. The sample solution and the control solution of 10 u1 were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, except for the peak of the auxiliary material (the peak of the relative retention time before 0.27) and the peak of lincomycin B, the chromatographic peak area with a retention time of about 0.72 relative to the lincomycin peak shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0% ) , the sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
- The Peak area of lincomycin B (relative retention time is about 0.53) shall not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B determined by the method under the item of content determination.
- others shall comply with the relevant provisions under ear drops (General rule 0126).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; With pH 6.1 buffer solution (34g of phosphoric acid, dissolved in 6.1 water, with concentrated ammonia solution to adjust the pH value, water was added to dilute to 1000ml)-methanol-acetonitrile (77:8:15) as mobile phase; The detection wavelength was 210nm. The sample solution 10 u1 under the items of related substances is injected into the liquid chromatograph, and the chromatogram is recorded. The resolution between the lincomycin peak and the chromatographic peak with a relative retention time of about 0.72 should be greater than 5.0.
- determine the appropriate amount of this product, quantitatively dilute it with mobile phase to a solution containing about 1 mg of lincomycin per 1 ml, shake well, and use it as a test solution, and inject l0ul into human liquid chromatograph with precise measurement, record the chromatogram; Take the appropriate amount of lincomycin reference, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with lincomycin hydrochloride.
specification
8ml:180mg (based on C18H34N206S)
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 15:05:59
lincomycin standard solution - Lincomycin hydrochloride eye drops
Authoritative Data Verified Data
This product contains lincomycin hydrochloride according to lincomycin (C18H34N206S) calculation, should be the label amount of 90.0% ~ 110.0%.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product and lincomycin reference substance, respectively, and add methanol to make a solution containing about 10 mg per 1 ml, which is used as the test solution and the reference solution, and identify according to the item of lincomycin hydrochloride (1) the same results were seen in one trial.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
- two items (1) and (2) above can be selected as one item.
examination
- the pH value should be 5.0 to 7.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing 8mg of lincomycin per 1ml, which should be used as a test solution; 1ml should be accurately measured and placed in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Tip density control solution 1ml, quantitative dilution with mobile phase to make a solution containing about 4ug of lincomycin per 1ml, as a sensitivity solution. According to the chromatographic conditions under the content determination item, the sensitivity solution 10u1 is injected into the human liquid chromatograph, and the signal-to-noise ratio of the peak height of the main component should be greater than 10; The sample solution and the control solution of 10 u1 are accurately measured, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, except for the peak of the auxiliary material (the peak of the relative retention time before 0.27), the peak of lincomycin B, the peak of benzoic acid, the peak of benzalkonium bromide and the peak of ethylparaben (if necessary, if sodium benzoate, benzalkonium bromide and ethylparaben can be used, the chromatographic peak area with a retention time of about 0.72 relative to the lincomycin peak shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
- lincomycin B was determined by the method under the content determination item, and the peak area of lincomycin B (relative retention time is about 0. 53) should not exceed 5.0% of the sum of the peak areas of lincomycin and lincomycin B.
- sodium benzoate, benzalkonium bromide and hydroxyphenylethyl chloride (if sodium benzoate, benzalkonium bromide and ethylparaben are used as preservatives), the mobile phase is added to dissolve and dilute to prepare about 8mg of sodium benzoate and 0 mg of benzalkonium bromide per 1 ml. A solution of 1 mg or 0.25mg of ethylparaben was used as a control solution. According to the chromatographic conditions under the content determination item, take each lol of the reference solution and the test solution under the item of related substances, respectively inject human liquid chromatography, and record the chromatogram. If the sample contains sodium benzoate, benzalkonium bromide or ethylparaben, the content shall be 80.0% ~ 120.0% of the labeled amount calculated by peak area according to external standard method.
- osmolality this product shall be taken and checked according to law (General rule 0632). The osmolality ratio shall be 0.9-1.1.
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; With pH 6.1 buffer solution (34g of phosphoric acid, dissolved in 6.1 water, with concentrated ammonia solution to adjust the pH value, water was added to dilute to 210 ml)-methanol-acetonitrile (77:8:15) as mobile phase; The detection wavelength was nm. The sample solution 10 u1 under the item of related substances is injected into the liquid chromatograph, and the chromatogram is recorded. The resolution between the lincomycin peak and the chromatographic peak with a relative retention time of about 0.72 should be greater than 5.0.
- The determination method takes an appropriate amount of this product, quantitatively dilutes it with mobile phase to prepare a solution containing about 1 mg of lincomycin per 1 ml, and shake it well to use it as a test solution. Take 10u1 injection of human liquid chromatograph for precision measurement, record the chromatogram; Take the appropriate amount of lincomycin reference, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with lincomycin hydrochloride.
specification
8ml:0.2g (based on C18H34N206S)
storage
light shielding, sealed, stored in the cool dark.
Last Update：2022-01-01 15:05:59
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Product Name: Lincomycin Hydrochloride Visit Supplier Webpage Request for quotationCAS: 859-18-7
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Lincocin Hydrochloride Request for quotation
CAS: 859-18-7
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
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CAS: 859-18-7
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
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