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Merck

PHR1159

Clindamycin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Clindamycin hydrochloride monohydrate, (7S)-7-Chloro-7-deoxylincomycin hydrochloride monohydrate

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Fórmula empírica (notación de Hill):
C18H33ClN2O5S · HCl · H2O
Número CAS:
58207-19-5
Peso molecular:
479.46
UNSPSC Code:
41116107
NACRES:
NA.24

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SMILES string

S([C@H]1O[C@@H]([C@@H]([C@@H]([C@H]1O)O)O)[C@H](NC(=O)[C@H]2[N+H](C[C@@H](C2)CCC)C)[C@@H](Cl)C)C.[Cl-].O

InChI

1S/C18H33ClN2O5S.ClH.H2O/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;1H2/t9-,10+,11-,12+,13-,14+,15+,16+,18+;;/m0../s1

InChI key

KWMXKEGEOADCEQ-WNNJHRBUSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. C225000, traceable to USP 1136002

API family

clindamycin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

Quality Level

300

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Clindamycin is a common antibiotic drug generally employed for the treatment of infections caused by gram-positive aerobes and both gram-negative and gram-positive anaerobic pathogens.

Application

Clindamycin hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and potentiometry techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAB7830 in the slot below. This is an example certificate only and may not be the lot that you receive.
Values of analytes vary lot to lot.

Clase de almacenamiento

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Liquid chromatography method for separation of clindamycin from related substances.
Orwa JA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 20(5), 745-752 (1999)
Sub-second adsorption for the fast sub-nanomolar monitoring of Clindamycin in its pure and pharmaceutical samples by fast Fourier transformation with the use of continuous cyclic voltammetry at an Au microelectrode in a flowing system
Norouzi P, et al.
Materials Science and Engineering, C, 28(1), 87-93 (2008)
John W Barlow et al.
BMC veterinary research, 9, 28-28 (2013-02-13)
Treatment of subclinical mastitis during lactation can have both direct (individual animal level) and indirect (population level) effects. With a few exceptions, prior research has focused on evaluating the direct effects of mastitis treatment, and to date no controlled field
Hui Wang et al.
Antimicrobial agents and chemotherapy, 57(3), 1538-1541 (2013-01-09)
A total of 146 group B streptococcus isolates from 8 cities across China belonged to four serotypes. Serotype Ia was more common in children. A high prevalence of resistance was observed for levofloxacin (37.7%), erythromycin (71.2%), clindamycin, (53.4%), and tetracycline
Orli Megged et al.
The Israel Medical Association journal : IMAJ, 15(1), 27-30 (2013-03-15)
Resistance to macrolides in beta-hemolytic streptococci and Streptococcus pneumoniae arises primarily due to Erm(B) or Mef(A). Erm(B) typically confers high level resistance to macrolides, lincosamides and streptogramin B (MLSB phenotype), whereas Mef(A) confers low level resistance to macrolides only (M
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