Indomethacin API is a well-established non-steroidal anti-inflammatory drug substance, commonly used in anti-inflammatory and analgesic formulations. As a mature NSAID API, Indomethacin remains an important raw material for pharmaceutical manufacturers, generic drug companies, distributors and formulation developers worldwide.
Huzhou Ureda Pharmaceutical Co., Ltd. supplies Indomethacin API CAS 53-86-1 with CEP, GMP and DMF support, helping customers meet quality, documentation and sourcing requirements for regulated and semi-regulated markets.
Basic Information of Indomethacin API
| Item | Information |
|---|---|
| Product Name | Indomethacin |
| Chinese Name | 吲哚美辛 |
| CAS No. | 53-86-1 |
| Molecular Formula | C19H16ClNO4 |
| Category | NSAID API |
| Standard | BP2022 |
| Documentation | CEP / GMP / DMF available |
| Typical Packing | 25 kg/drum |
| Application | Anti-inflammatory and analgesic formulations |
Why Indomethacin API Is Still in Demand
Although Indomethacin is a mature molecule, it continues to be widely used in pharmaceutical markets because of its established clinical history and broad formulation applications.
Pharmaceutical buyers usually source Indomethacin API for:
- Generic formulation development
- Anti-inflammatory drug manufacturing
- Analgesic formulations
- Hospital and prescription medicine supply
- Regulated market registration projects
- Commercial API sourcing
For this type of established API, customers usually care most about stable quality, reliable documentation, competitive supply and regulatory support.
CEP, GMP and DMF Support
For pharmaceutical manufacturers, documentation is a key factor when selecting an API supplier.
Our Indomethacin API can be supported with:
- CEP
- GMP
- DMF
- COA
- Specification
- MSDS
- Technical documents upon request
This makes the product suitable for customers working on formulation production, supplier qualification, registration preparation and commercial sourcing.
Quality Profile Based on BP2022
A recent batch of Indomethacin API was tested according to BP2022. The results showed good overall quality, including assay, impurity control, residual solvent compliance and microbial limit compliance.
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White or yellow crystalline powder | White crystalline powder |
| Melting Point | 158°C – 162°C | 160°C – 161°C |
| IR Identification | Corresponds to CRS | Complies |
| Any Unspecified Impurity | NMT 0.1% | 0.02% |
| Total Impurities | NMT 0.3% | 0.06% |
| Loss on Drying | NMT 0.5% | 0.1% |
| Sulfated Ash | NMT 0.1% | <0.1% |
| Residual Solvents | Ethanol ≤0.5%; Benzene ≤0.0002% | Complies |
| Assay | 98.0% – 102.0% | 100.6% |
| Microbial Limits | BP2022 requirement | Complies |
These data indicate that the product meets BP2022 requirements and is suitable for further customer evaluation.
Key Points for Indomethacin API Sourcing
When sourcing Indomethacin API, customers should evaluate more than price. Important points include:
- Pharmacopoeial compliance
- Assay and impurity profile
- Residual solvent control
- Microbial limit control
- CEP, GMP and DMF availability
- Batch COA and specification
- Supplier communication and export experience
A qualified supplier should be able to provide clear product identification, stable quality data and timely technical document support.
Huzhou Ureda Pharmaceutical: Indomethacin API Supplier
Huzhou Ureda Pharmaceutical Co., Ltd. supplies APIs and pharmaceutical raw materials for global customers. For Indomethacin API CAS 53-86-1, we can support sample evaluation, commercial quotation and documentation review.
We welcome inquiries from:
- Pharmaceutical manufacturers
- Generic drug companies
- CDMOs
- Formulation developers
- API distributors
- Sourcing teams
Product Summary
| Product | CAS No. | Standard | Documents | Application |
|---|---|---|---|---|
| Indomethacin API | 53-86-1 | BP2022 | CEP / GMP / DMF | Anti-inflammatory and analgesic formulations |
Contact Us for Indomethacin API CAS 53-86-1
If you are looking for Indomethacin API CAS 53-86-1 with CEP, GMP and DMF support, please contact us for availability, COA, specification and quotation.
Huzhou Ureda Pharmaceutical Co., Ltd.
Contact: Owen Lee
Email: sales@uredapharm.com
Website: www.uredapharm.com
WhatsApp: +86-18270717590
FAQ
What is Indomethacin API?
Indomethacin API is a non-steroidal anti-inflammatory drug substance used in anti-inflammatory and analgesic formulations.
What is the CAS number of Indomethacin?
The CAS number of Indomethacin is 53-86-1.
Is Indomethacin an NSAID?
Yes. Indomethacin belongs to the NSAID class.
Is CEP available for Indomethacin API?
Yes. CEP support is available.
Is DMF available for Indomethacin API?
Yes. DMF support is available.
Is GMP documentation available?
Yes. GMP support is available.
