21736-83-4
Spectinomycin Hydrochloride
CAS: 21736-83-4
Molecular Formula: C14H25ClN2O7
21736-83-4 - Names and Identifiers
| Name | Spectinomycin Hydrochloride |
| Synonyms | Spectinomycin HCl Spectinomycin Hydrochloride Spectinomycin dihydrochloride 8-beta,9-alpha,9a-alpha,10a-beta))-t SpectinoMycinHydrochloride for Injection 8-bis(methylamino)-,dihydrochloride,(2r-(2-alpha,4a-beta,5a-beta,6-beta,7-be 4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)decahydro-4H-pyrano[2,3-b][1,4]benzodioxin-4-one 4H-Pyrano(2,3-b)(1,4)benzodioxin-4-one, decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)- (2R,4aR,5aR,6S,7S,8R,9S,9aR,10aS)-decahydro-4a,7,9-trihydroxy-2-Methyl-6,8-bis(MethylaMino)-4H-pyrano[2,3-b][1,4]benzodioxin-4-one Hydrochloride |
| CAS | 21736-83-4 |
| EINECS | 244-554-3 |
| InChI | InChI=1/C14H24N2O7/c1-5-4-6(17)14(20)13(21-5)22-12-10(19)7(15-2)9(18)8(16-3)11(12)23-14/h5,7-13,15-16,18-20H,4H2,1-3H3 |
21736-83-4 - Physico-chemical Properties
| Molecular Formula | C14H25ClN2O7 |
| Molar Mass | 368.81 |
| Density | 1.43g/cm3 |
| Melting Point | 194°C |
| Boling Point | 583.1°C at 760 mmHg |
| Flash Point | 306.4°C |
| Solubility | H2O: 50mg/mL, clear, faintly yellow |
| Vapor Presure | 5.05E-16mmHg at 25°C |
| Appearance | Powder |
| Color | White to Off-White |
| Storage Condition | Inert atmosphere,2-8°C |
| Refractive Index | 1.586 |
| Physical and Chemical Properties | Spectinomycin belongs to alkaline antibiotics, the stronger the alkalinity, the stronger its antibacterial effect; But spectinomycin does not dissolve in water, so the most commonly used commercial drug is spectinomycin hydrochloride. Its quality assurance standards, eye view is white or white crystalline powder; It is soluble in water, water-soluble aqueous solution acidic test results, the pH of the 1% aqueous solution is 3.8-5.6. It is insoluble in organic solvents such as methanol, ethanol and propylene glycol. |
| Use | Mainly used for the treatment of urethritis caused by gonococcus, cervicitis, proctitis and acute gonorrhea and other diseases |
21736-83-4 - Risk and Safety
| WGK Germany | 2 |
| RTECS | WG7400000 |
| FLUKA BRAND F CODES | 10 |
21736-83-4 - Standard
Authoritative Data Verified Data
This product is [2R-(2a , 4aB, 5aB, 6B, 7B,8B,9a, 9aa,10aB)] decahydro-4a, 7, 9-trihydroxy-2-methyl-6, 8-dimethylamino-4h-pyrano [2,3-b] [ 1,4] benzodioxane-4-one dihydrochloride pentahydrate. The content of spectinomycin (C14H24N207) shall not be less than 77.9% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
21736-83-4 - Trait
Authoritative Data Verified Data
- white or off-white crystalline powder
- This product is soluble in water, almost insoluble in ethanol or ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about lOOmg per lml, and determine according to law (General rule 0621). The specific rotation is 15 ° to 21 °.
Last Update：2022-01-01 14:20:22
21736-83-4 - Differential diagnosis
Authoritative Data Verified Data
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1007).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0512).
Last Update：2022-01-01 14:20:23
21736-83-4 - Exam
Authoritative Data Verified Data
crystallinity
take 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 about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 3.8~5.6.
clarity and color of solution
take 5 parts of this product, each 0.75g, respectively, add water 0902, dissolved, the solution should be clear and colorless; If it is turbid, compare with No. 1 turbidity standard solution (General rule first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow No. 6 Standard Colorimetric solution (General Principles 0901 first method).
Related substances
new system for clinical use. Take an appropriate amount of spectinomycin reference substance, weigh it precisely, add water to dissolve and quantitatively dilute to prepare solutions containing 17ug, 80ug and 170ug of spectinomycin respectively per lml as reference solution (1), (2), (3). Take an appropriate amount of spectinomycin reference substance, weigh it precisely, add water to dissolve and quantitatively dilute to prepare a solution containing about 10ug spectinomycin per 1 ml, which is used as a sensitive solution. According to the chromatographic conditions under the content determination item, the sensitivity solution 20ul is injected into the liquid chromatograph, and the chromatogram is recorded. The signal-to-noise ratio of the peak peak of spectinomycin should be greater than 10. Accurately take the reference solution (1), (2) and (3) each 20 u1, respectively injected into the liquid chromatograph, record the chromatogram, the linear regression equation is calculated by the logarithmic value of the solution concentration of the reference substance and the logarithmic value of the corresponding peak area, and the correlation coefficient (r) should not be less than 0.99, water was added to dissolve and quantitatively dilute to prepare a solution containing about 3.5mg spectinomycin per 1 ml, which was determined by the same method, and the chromatogram was 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, it is calculated by linear regression equation, containing impurity D (relative retention time is about 0.7) and impurity E (relative retention time is about 0.9). All shall not exceed 4.0%, other individual impurities shall not exceed 1.0%, and the total amount of impurities shall not exceed 6.0%, and the content of (4R)-dihydrospectinomycin (relative retention time is about 1.6) shall be calculated.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 16.0% ~ 20.0%.
ignition residue
less than 1.0% (General 0841k
aspiration test
Take 2g of this product, add benzyl alcohol injection 3.2ml, make a suspension, with a syringe with a 7 needle, should be able to pass smoothly, not blocked.
visible foreign body
take 5 parts of this product, and add particles to check after dissolving with water, check according to law (General rule 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 copies of this product, check according to law (General 0903), each lg of sample, containing lOum and more than 6000 particles, no more than 600 particles containing 25um and more than 25um. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg spectinomycin should be less than 0.075EIL (for injection)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 14:20:24
21736-83-4 - 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 as filler (pH range 0.8~8.0); 0.1 mol/L trifluoroacetic acid solution as mobile phase, flow rate of 0.6ml per minute; Detection with evaporative light scattering detector (high temperature non-split mode detector reference conditions: drift tube temperature of 110°C, the carrier gas flow rate is 2.6L per minute, the gain coefficient is 1; The reference conditions of the low temperature shunt mode detector are: the drift tube temperature is 70°C, the carrier gas flow rate is 20ul, the gain coefficient is 100, nebulizer mode is heating, power level 60%; Other mode of the detector can be set according to the actual situation). Take an appropriate amount of spectinomycin reference substance, weigh it precisely, dissolve it with water and dilute it to make a solution containing about 3.5mg spectinomycin per 1 ml. Inject 20u1 into human liquid chromatograph and record the chromatogram. The chromatogram of the reference solution should be consistent with the standard chromatogram of spectinomycin, and the separation degree between spectinomycin peak and impurity E Peak (relative retention time is about 0.9) should be not less than 1.0.
assay
take an appropriate amount of spectinomycin reference substance, weigh it precisely, add water to dissolve and quantitatively dilute it to prepare solutions containing about 0.15mg, 0.35mg and 0.70mg of spectinomycin per 1 ml as the reference solution (1), (2), (3). Accurately measure 20 u1 of each of the above three solutions, respectively inject human liquid chromatography, record the chromatogram, and calculate the linear regression equation with the logarithmic value of the concentration of the reference solution and the corresponding peak area pair value, the correlation coefficient (r) should not be less than 0.99; Take an appropriate amount of this product, precision weighing, water dissolution and quantitative dilution to make a solution containing about 0.35mg spectinomycin per lml, and determine with the same method, the content of spectinomycin (C14H24N207) in the test product was calculated by linear regression equation, and the sum of the content of (4R)-dihydrospectinomycin measured under the related substance inspection item was taken as the content of C14H24N207.
Last Update：2022-01-01 14:20:25
21736-83-4 - Category
Authoritative Data Verified Data
aminoglycoside antibiotics.
Last Update：2022-01-01 14:20:25
21736-83-4 - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 14:20:25
21736-83-4 - Spectinomycin Hydrochloride for Injection
Authoritative Data Verified Data
This product is a sterile powder of spectinomycin hydrochloride. The content of spectinomycin (C14H24N207) shall not be less than 77.9% based on the calculation of anhydrous substance; The content of spectinomycin (C14H24N207) shall be 90.0% ~ 110.0% of the labeled amount based on the average loading.
trait
This product is white or off-white crystalline powder.
identification
According to the identification test under the item of spectinomycin hydrochloride, the same results were shown.
examination
- the clarity and color of the solution take 5 bottles of this product, and add water to make a solution containing 0.12g per lml according to the marked amount. The solution should be clear and colorless, if it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), shall not be more concentrated. If the color is developed, it shall not be deeper than that of the Yellow 6# Standard Colorimetric solution (General Principles 0901 first method).
- suspension time and needle test take 1 bottle of this product, add 3.2ml benzyl alcohol injection to make a suspension, shake well, stand for 2 minutes, no particles sink or obvious stratification, draw with a syringe fitted with a 7-gauge needle, which should pass smoothly, without blocking.
- acidity, related substances, moisture, bacterial endotoxin and sterility shall be checked according to the method of spectinomycin hydrochloride, and shall comply with the regulations.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were collected, mixed uniformly, accurately weighed to take an appropriate amount, and measured according to the method under the item of spectinomycin hydrochloride. 1 mg of C14H24N2O7 corresponds to 1000 spectinomycin units.
category
with spectinomycin hydrochloride.
specification
2g(2 million units) (based on C14H24N207)
storage
sealed and stored in a dry place.
Last Update：2022-01-01 14:20:26
21736-83-4 - Reference Information
| antibiotics | spectinomycin hydrochloride is produced by streptomyces. it is an aminoglycoside fast bactericidal antibiotic formed by the combination of neutral sugar and aminocyclohydrin. it also has a name called spectinomycin. It was discovered by American Mason and others in 1961 in the last century. It is used in the clinical treatment of livestock and poultry veterinarians, and is mainly used to treat diseases caused by E. coli, Salmonella, Pasteurella and Mycoplasma caused by sensitive bacterial infections. spectinomycin hydrochloride for injection is a special Junior College drug for gonorrhea first developed by Lu Anti Medicine in China. spectinomycin hydrochloride for injection is recommended by the World Health Organization WHO and the Ministry of Health as the first choice for gonorrhea. Luying Pharmaceutical is the only domestic enterprise with the production capacity of spectinomycin hydrochloride raw material, ranking first in the domestic Daguan powder injection market for eight consecutive years. |
| pharmacokinetics | spectinomycin hydrochloride is absorbed rapidly by intramuscular injection. the blood drug concentration in healthy animals can reach the peak after intramuscular injection for 1 hour. by 6 hours, the blood drug concentration in the body is still above the effective inhibitory concentration, which is at a relatively high effective level. The level of blood drug concentration increases with the increase of dose. spectinomycin is mainly excreted through the kidneys, usually after 6 hours, its excretion accounts for about 45% of the total dosage. |
| mechanism of action | the antibacterial mechanism of spectinomycin hydrochloride, like other aminoglycoside antibiotics, also selectively acts on the 30s subunit of the bacterial cell nucleus proteome after entering the bacterial cell, thus producing a strong inhibitory effect on the protein synthesis of bacterial cells and a strong killing effect on sensitive bacteria. |
| Bactericidal effect | Spectinomycin hydrochloride is a broad-spectrum rapid fungicide. It is effective against Escherichia coli, Salmonella, Pasteurella, Proteus, Streptococcus pneumoniae, Streptococcus pneumoniae, Pneumoniae, etc. have a strong effect; therefore, it has a good clinical therapeutic effect on the treatment of infectious diseases caused by the above-mentioned sensitive bacteria. It has inhibitory effect on Gram-positive and negative bacteria. It has a strong antibacterial effect on Neisseria gonorrhoeae, and has good antibacterial activity on Neisseria gonorrhoeae that produce B- lactamase. It is a new type of specific drug for gonorrhea. |
| indications | is used to treat co-infection of g-bacteria, mycoplasma and mycoplasma and bacteria. Mainly used for the prevention and treatment of piglets E. coli, Salmonella, Pasteurella, mycoplasma infection. |
| toxicity | spectinomycin hydrochloride has very low toxicity. Some researchers used mice and rats to carry out toxicological experiments on intraperitoneal, subcutaneous, intramuscular and oral administration routes. Rats were injected intramuscularly with spectinomycin 500, 250, 100, 50mg/(kg d) for 32 days, and intraperitoneal with spectinomycin 700, 400, 200, 50/(kg d) for 39 days to observe its subacute toxicity. |
| combination drug | this product can be combined with lincomycin, has high antibacterial effect on g bacteria and g-bacteria, and can significantly enhance the antibacterial activity against mycoplasma. it is mainly used to control pig dysentery, bacterial enteritis, mycoplasma disease and mycoplasma and bacterial infection caused by Escherichia coli and salmonella. For the clinical oral treatment of livestock and poultry, spectinomycin hydrochloride and the current clinical common drugs can be used in combination, and most of them show synergistic antibacterial effect. Since spectinomycin is a basic antibiotic, when it is combined with some alkaline drugs, such as tilmicosin, tylosin, sodium bicarbonate, etc., its antibacterial efficacy will be significantly enhanced. In the aspect of synergistic antibacterial of combined drugs, spectinomycin hydrochloride and penicillins, cephalosporins, amidols, macrolides, tetracyclines, fluoroquinolones and other antibiotics have synergistic antibacterial effects, and the antibacterial efficacy of compound drugs will be greatly improved. Of course, there is also an optimal ratio between the two drugs, which needs to be evaluated by extensive drug sensitivity experiments for different pathogens. |
| adverse reactions | this product is relatively less toxic and rarely causes nephrotoxicity and ototoxicity. But like other aminoglycosides, it can cause neuromuscular blockade, and calcium injection can be used for first aid. |
| precautions | this product cannot be combined with florfenicol or tetracycline, showing antagonistic effect. |
| use | mainly used to treat urethritis, cervicitis, proctitis and acute gonorrhea caused by gonococcus |
Last Update：2024-04-09 20:49:11
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Spot supply
Product Name: Spectinomycin Dihydrochloride Visit Supplier Webpage Request for quotationCAS: 21736-83-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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