PHR1950

Spiramycin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Spiramycin, Formacidine
• CAS Number: 8025-81-8
• UNSPSC Code: 41116107
• NACRES: NA.24
• EC Number: 232-429-6
• MDL number: MFCD01314545

Properties

• Quality Level: 300
• grade: certified reference material, pharmaceutical secondary standard
• agency: traceable to Ph. Eur. S1100000
• API family: spiramycin
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• application(s): pharmaceutical
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: CO[C@H]1[C@H](O)CC(=O)O[C@H](C)C\C=C\C=C\[C@H](OC2CCC(C(C)O2)N(C)C)[C@H](C)C[C@H](CC=O)[C@@H]1OC3OC(C)C(OC4CC(C)(O)C(O)C(C)O4)C(C3O)N(C)C
• InChI: 1S/C43H74N2O14/c1-24-21-29(19-20-46)39(59-42-37(49)36(45(9)10)38(27(4)56-42)58-35-23-43(6,51)41(50)28(5)55-35)40(52-11)31(47)22-33(48)53-25(2)15-13-12-14-16-32(24)57-34-18-17-30(44(7)8)26(3)54-34/h12-14,16,20,24-32,34-42,47,49-51H,15,17-19,21-23H2,1-11H3/b13-12+,16-14+/t24-,25-,26?,27?,28?,29+,30?,31-,32+,34?,35?,36?,37?,38?,39+,40+,41?,42?,43?/m1/s1
• InChI key: ACTOXUHEUCPTEW-JMRHEKERSA-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

Spiramycin belongs to the macrolide group of antibiotics, widely used in the treatment of respiratory tract, skin and skin-structure, sexually transmitted, and various other infections. Spiramycin is derived from the culture filtrate of Streptomyces ambofaciens and its mode of action involves the exibition of antimicrobial activity by inhibiting ribosomal protein biosynthesis.

Application

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.

Spiramycin may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using liquid chromatography technique.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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 LRAB1418 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable