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Atorvastatin Hemicalcium Trihydrate (API) is a synthetic statin and HMG-CoA reductase inhibitor. It reduces LDL cholesterol and cardiovascular risks, used for primary hyperlipidaemia, mixed dyslipidaemia, and cardiovascular prevention.
As an API, its key selling points are:
High Purity & Low Impurities — ensures regulatory compliance (USP/EP/ChP) and efficacy.
Stable Crystalline Form — controlled trihydrate polymorph guarantees consistent flow and dissolution.
Regulatory Readiness — supported by US DMF/CEP and cGMP production, streamlining generic registration.
Specifications of Atorvastatin Calcium Salt Trihydrate CAS 344423-98-9 COA:
Items | Specifications | Results |
Appearance (25℃) | White or off-white powder | Conforms |
Identification | IR:Positive Calcium:The sample exhibits a significant absorption at the calcium emission line at 422.7nm | Conforms Conforms |
Enantiomeric impurity(HPLC) | Not more than 0.3% | ND |
Related Substances(HPLC) | ||
Atorvastatin diamino | Not more than 0.15% | 0.03% |
Desfluoro Atorvastatin | Not more than 0.3% | ND |
3S,5R isomer | Not more than 0.3% | ND |
Difluoro Atorvastatin | Not more than 0.3% | 0.05% |
3-deoxy-hept-2-enoic acid | Not more than 0.10% | ND |
Atorvastatin lactone | Not more than 0.15% | NR |
Epoxy tetrahydrofuran analog | Not more than 0.15% | ND |
Atorvastatin ethyl ester | Not more than 0.15% | ND |
Atorvastatin Epoxide | Not more than 0.15% | NR |
Acetonide impurity | Not more than 0.15% | ND |
Any other individual impurity | Not more than 0.10% | 0.04% |
Total impurities | Not more than 1.0% | 0.15% |
Water(K.F.) | Not more than 6.0% | 2.8% |
X-RAY Diffraction | Amorphous | Complies |
ASSAY (HPLC, on anhydrous basis) | 98.0%-102.0% | 100.1% |
PSD | D90<10μm | 8μm |
Residual solvents(GC) Methanol Methyl tert-butyl ether | Not more than 0.3% (3000ppm) Not more than 0.5% (5000ppm) | 12ppm 30ppm |
Conclusion | The product conforms to the above specifications. | |
Product Name:Atorvastatin Calcium Salt Trihydrate
CAS:
MF:
Melting point :
form:powder
color:White, yellow-white or grayish-white
Uses:
Hyperlipidaemia: primary hypercholesterolaemia (including heterozygous familial) and mixed dyslipidaemia — lowers total-C, LDL-C, apo B and triglycerides, and raises HDL-C.
Homozygous familial hypercholesterolaemia (HoFH): alone or with LDL apheresis.
Cardiovascular risk reduction: lowers the risk of non-fatal MI, fatal/non-fatal stroke, revascularisation procedures, angina, and hospitalisation for CHF in patients with CHD or multiple risk factors (including type 2 diabetes).
Paediatric HeFH: ages 10–17 years after inadequate diet response.
Common dose forms: oral tablets 10/20/40/80 mg, once daily; also used in fixed-dose combinations (e.g., with ezetimibe or amlodipine).
High assay & low impurities — tight control of related substances (individual/specified impurities and total impurities), residual solvents and heavy metals supports USP/EP/ChP compliance and smooth generic registration.
Defined crystalline form & consistent hydration — the stable trihydrate form with controlled polymorph/particle size (PSD) gives predictable flow, content uniformity and dissolution, reducing batch-to-batch variability in tablets.
Regulatory readiness — availability of US DMF, CEP/EDMF, and other market DMFs (EU, Japan, Canada, Brazil, China) plus cGMP manufacture shortens the buyer's filing timeline.
Large, mature market — one of the world's most-prescribed drugs with steady demand in both monotherapy and combination products, offering reliable volume and competitive pricing.
Supply-chain practicality — light-protected, sealed, dry storage with a typical 24–36 month shelf life; scalable kg-to-tonne production capacity.
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Atorvastatin Calcium Salt Trihydrate with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Atorvastatin Calcium Salt Trihydrate.
1. Guaranteed purity;
2. Large quantity in stock;
3. Largest manufacturer;
4. Best service after shipment with email;
5. High quality & competitive price;
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