(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Names and Identifiers
Name | clindamycin hydrochloride
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Synonyms | Lujiemycin CLINDAMYCIN HC Clindamycin HCl ClidamycinHydrochloride clindamycin hydrochloride CLINDAMYCINHYDROCHLORIDE,USP CLINDAMYCINHYDROCHLORIDE,CRYSTAL Clindaymcin Hydrochloride BP98,USP25,EP97 Clindamycin hydrochloride, Antibiotic for Culture Media Use Only monohydrochloride,(2s-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio methyl 7-chloro-6,7,8-trideoxy-6-({[(2R)-1-methyl-4-propylpyrrolidinium-2-yl]carbonyl}amino)-1-thio-beta-L-erythro-octopyranoside chloride L-threo-.alpha.-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-(2S,4R)-1-methyl-4-propyl-2-pyrrolidinylcarbonylamino-1-thio-, monohydrochloride (2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride
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CAS | 21462-39-5
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EINECS | 244-398-6 |
InChI | InChI=1/C18H33ClN2O5S.ClH/c1-5-6-10-7-11(21(3)8-10)17(25)20-12(9(2)19)16-14(23)13(22)15(24)18(26-16)27-4;/h9-16,18,22-24H,5-8H2,1-4H3,(H,20,25);1H/t9?,10-,11+,12?,13+,14-,15-,16-,18-;/m0./s1 |
InChIKey | AUODDLQVRAJAJM-XJQDNNTCSA-N |
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Physico-chemical Properties
Molecular Formula | C18H34Cl2N2O5S
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Molar Mass | 461.44 |
Melting Point | 141°C |
Boling Point | 647°C at 760 mmHg |
Flash Point | 345.1°C |
Solubility | H2O: 50mg/mL, clear, colorless |
Vapor Presure | 1.79E-19mmHg at 25°C |
Appearance | White crystalline powder |
Color | White to Off-White |
BRN | 4070786 |
Storage Condition | 2-8°C |
Stability | Hygroscopic |
MDL | MFCD07793327 |
Physical and Chemical Properties | Melting Point: 141°C |
Use | Lincomycin derivatives, Staphylococcus aureus, Pneumonia cocci bactericidal activity many times stronger than lincomycin |
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Risk and Safety
Hazard Symbols | Xi - Irritant
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Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin.
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Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S37/39 - Wear suitable gloves and eye/face protection
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WGK Germany | 2 |
RTECS | GF2275000 |
FLUKA BRAND F CODES | 10 |
HS Code | 29419000 |
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Upstream Downstream Industry
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Reference
Reference Show more | 1. Wang Meng, Bi Qianyu, Shang Linlin, et al. Study on Bacteriostasis and Skin Irritation in Compound Clindamycin Liposome [J]. Northwest Journal of Pharmacy, 2019, 034(006):775-778. 2. Wang Meng, Shang Linlin, Lu Chuanfeng, et al. Preparation of Compound Clindamycin Liposome Gel and Study on Transdermal Release in Vitro [J]. Northwest Journal of Pharmacy, 2019, 034(004):530-533. 3. Nie Hemin, Zhang Zongyao, Huang Yumei, et al. Drug Resistance Investigation and PFGE Typing of Campylobacter Chickens in Guangdong Province [J]. Chinese Veterinary Science, 2018, 048(010):1265-1271. 4. [IF = 4.36] Qingsong Qu et al."Effects of fermented ginseng on the gut microbiota and immunity of rats with antibiotic-associated diarrhea." J Ethnopharmacol. 2021 Mar;267:113594 |
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Standard
Authoritative Data Verified Data
This product is 7-chloro-6, 7, 8-dideoxy-6- (l-methyl-trans-4-propyl-L-2-pyrrolidinylamino) 1-thio-L-threonine-a-D-pyrrogalactopyranoside IV hydrochloride. Clindamycin (C18H33C1N205S) shall not be less than 83.0% calculated as anhydrous.
Last Update:2024-01-02 23:10:35
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is easily soluble in water, soluble in methanol or pyridine, slightly soluble in ethanol, almost insoluble in acetone.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 40mg per lml solution, according to the law (General 0621), specific rotation of 135 ° to 150 °.
Last Update:2022-01-01 15:04:45
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product and the reference substance of clindamycin, 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 clindamycin control and lincomycin control, and add methanol to make a mixed solution containing 10 mg of clindamycin and 10 mg of lincomycin per 1 ml. Test according to thin layer chromatography (General rule 0502), 2ul of each of the above three Solutions was absorbed, respectively, on the same silica gel G thin layer plate, with ethyl acetate-formic acid (1.5:1) as the developer, developed, dried, and colored in iodine vapor. The mixed solution should show two clearly separated spots. The position and color of the main spot displayed by the test solution should be consistent with 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 the control (Spectrum set 352). If it is found that the absorption peak at 1680-1050cm-1 is inconsistent with the spectrum of the control, it is advisable to take an appropriate amount of this product, add a small amount of methanol to dissolve it, and then evaporate it on a water bath, and measure it after drying under reduced pressure.
- 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.
Last Update:2022-01-01 15:04:45
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - 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 O.lg per lml, check according to law (General 0631) ,pH value should be 3.0~5.5.
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make 4.0 mg of the solution was used as the test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing about 80ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of lincomycin (relative retention time is about 0.4) shall not be greater than 0.5 times (1.0%) of the main peak area of the control solution, clindamycin B (relative retention time is about 0.65) Peak area should not be greater than the control solution Main Peak area (2.0%),7-to clindamycin (relative retention time is about 0.8) the peak area shall not be greater than 0.75 times (1.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than 0.25 times (0.5%) of the main peak area of the control solution, the sum of each impurity peak area shall not be greater than 3 times (6.0%) of the main peak area of the control solution.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
ignition residue
not more than 0.5% (General rule 0841).
Last Update:2022-01-01 15:04:46
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - 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; Potassium dihydrogen phosphate solution (6.8mg of potassium dihydrogen phosphate per 1 ml, adjusted to pH 25% with 7.5 potassium hydroxide solution)-acetonitrile (55:45) as the mobile phase; The detection wavelength is 210mn; Take an appropriate amount of clindamycin control, add the mobile phase to dissolve and dilute to make 4 per 1 ml. 0 mg of the solution, 20 U1 was injected into the liquid chromatograph, and the chromatogram was recorded; The retention time of the main peak of clindamycin was about 10 minutes. Clindamycin B Peak (relative retention time about 0.65) and 7-episodic clindamycin peak (relative retention time about 0.8) and the 7-episodic clindamycin peak should be separated from the clindamycin peak by greater than 3.0.
assay
take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake it well, and use it as a test solution, the chromatogram was recorded by injection of 20u1 into human liquid chromatograph, and an appropriate amount of clindamycin reference substance was taken for determination by the same method. The content of c18h33c1n205 S was calculated by peak area according to external standard method.
Last Update:2022-01-01 15:04:47
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:04:47
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Storage
Authoritative Data Verified Data
Last Update:2022-01-01 15:04:47
(2R,4S)-N-[2-chloro-1-[(2S,3S,4R,5S,6S)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide hydrochloride - Clindamycin hydrochloride capsules
Authoritative Data Verified Data
This product contains clindamycin hydrochloride according to clindamycin (C18H33CIN205S) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white powder or crystalline powder or granules.
identification
- take an appropriate amount of the contents of this product, add methanol to make a solution containing 10 mg of clindamycin per 1 ml, shake for 2-3 minutes, stand still, and take the supernatant as the test solution, according to clindamycin hydrochloride under identification (1) test, showed the same results.
- 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
- the contents under the item of difference in loading amount of related substances should be mixed uniformly, and the appropriate amount (about equivalent to clindamycin lOOmg) should be accurately weighed and taken, add mobile phase to dissolve and dilute to make clindamycin in about 1 ml 4.0 mg of solution, filtration, take the filtrate, according to the method under the item of clindamycin hydrochloride determination, should comply with the provisions.
- water the content of this product should be taken in an appropriate amount, and the water content should not exceed 0832 as determined by the moisture determination method (General rule 7.0%, first method 1).
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about equivalent to clindamycin 0.lg) accurately, put it in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate as a test solution, according to the method under the item of clindamycin hydrochloride, obtained.
category
with clindamycin hydrochloride.
specification
Based on C18H33C1N205S (l)0.075g (2)0.lg(3)0.15g
storage
sealed storage.
Last Update:2022-01-01 15:04:48