PHR1159

Clindamycin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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
• 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

Description

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.[1]

Application

Clindamycin hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography[2][1] and potentiometry[3] 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.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable