Atorvastatin Calcium
SIAL/PHR1422 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Atorvastatin hemicalcium salt sesquihydrate; 1H-Pyrrole-1-heptanoic acid, [R-(R*,R*)
CAS Number: 344423-98-9
Empirical Formula (Hill Notation): C66H68CaF2N4O10 · 3H2O
Molecular Weight: 1209.39
Linear Formula: C66H68CaF2N4O10 · 3H2O
Product Type: Chemical
agency | traceable to Ph. Eur. Y0001327 |
traceable to USP 1044516 | |
API family | atorvastatin |
application(s) | pharmaceutical (small molecule) |
CofA | current certificate can be downloaded |
format | neat |
grade | certified reference material |
pharmaceutical secondary standard | |
InChI | 1S/2C33H35FN2O5.Ca.3H2O/c |
InChI key | SHZPNDRIDUBNMH-NIJVSVLQSA |
Quality Level | 300 |
storage temp. | 2-30°C |
technique(s) | gas chromatography (GC): suitable |
HPLC: suitable |
Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. |
Application: | Azathioprine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography (RP-HPLC) and spectrophotometric techniques. |
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. |
Footnote: | To see an example of a Certificate of Analysis for this material enter LRAC0148 in the slot below. This is an example certificate only and may not be the lot that you receive. |
General description: | Atorvastatin Calcium is a synthetic cholesterol lowering agent, which acts as an inhibitor of 3-hydroxy-3-methyl glutaryl coenzyme A reductase. It is widely used in combination with amlodipine besylate as a medication in the treatment of vasospastic angina, hypertension, chronic stable angina and primary dysbetalipoproteinemia. 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. |
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. |
Symbol | GHS08 |
Signal word | Danger |
Hazard statements | H351 - H360D |
Precautionary statements | P201 - P202 - P280 - P308 + P313 - P405 - P501 |
Hazard Codes | T |
Risk Statements | 61-36 |
Safety Statements | 53-26-45 |
RIDADR | NONH for all modes of transport |
WGK Germany | WGK 3 |
Flash Point(F) | Not applicable |
Flash Point(C) | Not applicable |
Storage Temp. | 2-30°C |
UNSPSC | 41116107 |
Components | Atorvastatin hemicalcium salt sesquihydrate |