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PHR1159

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Clindamycin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Clindamycin hydrochloride monohydrate, (7S)-7-Chloro-7-deoxylincomycin hydrochloride monohydrate
Empirical Formula (Hill Notation):
C18H33ClN2O5S · HCl · H2O
CAS Number:
58207-19-5
Molecular Weight:
479.46
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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

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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, EP (PhEur) and BP 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.
Values of analytes vary lot to lot.

Footnote

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.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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
Ronald N Jones et al.
Diagnostic microbiology and infectious disease, 75(3), 304-307 (2013-01-30)
Dalbavancin (DAL) is an investigational lipoglycopeptide with a prolonged serum half-life allowing once weekly dosing. DAL potency was assessed in the 2011 SENTRY Antimicrobial Surveillance Program among 1555 isolates sampled from all 9 US Census regions. Monitored Gram-positive cocci included
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)
Katrin Schilcher et al.
The Journal of infectious diseases, 210(3), 473-482 (2014-02-15)
The Gram-positive human pathogen Staphylococcus aureus causes a variety of human diseases such as skin infections, pneumonia, and endocarditis. The micrococcal nuclease Nuc1 is one of the major S. aureus virulence factors and allows the bacterium to avoid neutrophil extracellular
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