Indomethacin API Manufacturer China | ≥98% NSAID Anti-Inflammatory Powder CAS 53-86-1

Key Selling Points

✓ Potent Non-Selective COX Inhibitor - COX-1 IC50 740 nM / COX-2 IC50 970 nM, Strong Anti-Inflammatory & Analgesic

✓ Indole-Acetic Acid NSAID - Classic Reference Compound for Inflammation, Pain & Fever Research

✓ Dual Mechanism - COX Inhibition + Phospholipase A2 Inhibition (IC50 145 μM)

✓ Narrow Therapeutic Index - High GI Toxicity (Canine Therapeutic Doses May Cause Ulceration, Hematemesis, Melena)

✓ Research-Grade API - Widely Used in Inflammation, Pain, Fever, PDA & Amyloidosis Experimental Models

✓ Strict Quality Control - ≥98% HPLC, Full COA, Identity & Impurity Verification

What Is Indomethacin Powder?

Indomethacin Powder (C₁₉H₁₆ClNO₄, MW 357.79) is a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the indole-acetic acid derivative class. Chemically it is 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. It is a non-selective cyclooxygenase (COX) inhibitor with IC50 values of 740 nM for COX-1 and 970 nM for COX-2, and also inhibits phospholipase A2 (IC50 145 μM). By reducing prostaglandin synthesis, it exerts strong anti-inflammatory, analgesic and antipyretic effects.

It is widely used as a pharmaceutical and research raw material for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, postoperative pain, fever and patent ductus arteriosus (PDA) in preterm infants in human medicine. In veterinary and experimental settings, it serves as a classic reference compound for inflammation, pain and fever research models. Important: it has a narrow therapeutic index and high gastrointestinal toxicity - in dogs, therapeutic doses may cause severe gastric ulceration, hematemesis and melena, so it is not recommended for routine canine use. It also inhibits transthyretin (TTR) amyloid fibril formation and suppresses Aβ peptide production in research models.

How Does Indomethacin Powder Work?

Indomethacin Powder exerts its anti-inflammatory, analgesic and antipyretic effects primarily through non-selective inhibition of cyclooxygenase (COX-1 and COX-2), the enzymes that catalyze the conversion of arachidonic acid to prostaglandins (PGE2, PGI2, TXA2). By reducing prostaglandin synthesis at inflammatory sites, it decreases vasodilation, edema, pain sensitization and fever. It also inhibits phospholipase A2, reducing arachidonic acid release from cell membranes.

Because Indomethacin Powder is non-selective, it also inhibits constitutive COX-1, which is responsible for gastrointestinal mucosal protection (mucus and bicarbonate secretion, mucosal blood flow), renal blood flow autoregulation and platelet aggregation. This explains its high incidence of GI ulceration, renal impairment and bleeding risk. At high doses, it may cause CNS effects (headache, dizziness, ataxia) and hepatic injury. Metabolism is hepatic; excretion is renal (~60%) and biliary. Oral bioavailability is ~98% with 90% plasma protein binding. Half-life varies by species: dogs 4–6 h, cats 1 h, horses 1 h, cattle 0.5 h.

What Are the Applications of Indomethacin Powder?

Human Rheumatology: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gouty arthritis, acute shoulder pain.
Human Pain & Fever: Postoperative pain, moderate-to-severe pain, fever reduction.
Neonatal PDA: Patent ductus arteriosus closure in preterm infants (IV formulation).
Research - Inflammation Models: Classic reference NSAID for carrageenan paw edema, adjuvant arthritis, air pouch inflammation.
Research - Pain Models: Acetic acid writhing, formalin test, hot plate analgesia studies.
Research - Fever Models: Yeast-induced or LPS-induced pyrexia studies.
Research - Amyloidosis: TTR amyloid fibril formation inhibition, Aβ peptide suppression studies.
Veterinary (Caution): Horses - anti-inflammatory/analgesic (use with caution due to GI and renal toxicity); Birds - occasional anti-inflammatory use; Dogs - NOT recommended for routine use due to severe GI toxicity at therapeutic doses.
Pharmaceutical Formulations: Raw material for capsules, tablets, suppositories, oral suspensions, injectable solutions and topical gels.

What Is the Difference Between Indomethacin and Other NSAIDs?

Feature	Indomethacin	Phenylbutazone	Flunixin Meglumine	Carprofen	Meloxicam
CAS	53-86-1	50-33-9	42461-84-7	53716-49-7	71125-38-7
Class	Indole-acetic acid	Pyrazolone	Nicotinic acid derivative	Propionic acid	Oxicam
COX Selectivity	Non-selective (COX-1 preferential)	Non-selective	Non-selective (COX-1 preferential)	Preferential COX-2	Selective COX-2
Anti-Inflammatory Potency	Very high	High	Very high	Moderate	Moderate-high
GI Toxicity	Very high (especially dogs)	High	High (horses: colitis)	Moderate	Low-moderate
Renal Toxicity	High	High	High	Moderate	Moderate
Veterinary Use	Limited (dogs not recommended)	Horses, dogs (older)	Horses, cattle, pigs	Dogs, cats	Dogs, cats, cattle
Half-life (dog)	4–6 h	2–6 h	2–6 h	8 h	24 h

How Does Indomethacin Compare With Other COX Inhibitors?

Feature	Indomethacin	Ketoprofen	Ibuprofen	Naproxen	Diclofenac
CAS	53-86-1	22071-15-4	15687-27-1	22204-53-1	15307-86-5
COX-1/COX-2 IC50 Ratio	~0.76 (COX-1 preferential)	~0.25	~0.1	~0.1	~0.1
Potency	Very high	High	Low-moderate	Moderate	High
Analgesic	Strong	Strong	Moderate	Moderate	Strong
Antipyretic	Strong	Moderate	Moderate	Moderate	Strong
GI Risk	Very high	High	Moderate	Moderate-high	High
Typical Use	Severe inflammation, gout, PDA	Pain, inflammation	Mild pain, fever	Pain, inflammation	Pain, inflammation
Veterinary Use	Limited	Horses, dogs, cats	Limited (dogs toxic)	Limited (dogs very toxic)	Limited

How Is Indomethacin Powder Manufactured?

Indomethacin Powder is manufactured through multi-step chemical synthesis involving indole ring formation, chlorobenzoylation, methylation and acetic acid side chain introduction.

Raw Material QC → Starting Material (5-Methoxy-2-methylindole / p-Chlorobenzoyl chloride) → N-Chlorobenzoylation → C3-Alkylation (Ethyl Bromoacetate) → Hydrolysis → Crude Indomethacin Acid → Purification (Recrystallization) → Drying → Milling → Final QC → Packaging

HDM BIO controls key chlorobenzoylation, alkylation and recrystallization parameters to maintain consistent purity, particle size and batch quality.

Quality Specifications

Test Item	Standard	Typical Result
Appearance	White to off-white powder	Consistent
Assay (HPLC)	≥98.0%	99.0%
Identity (IR / HPLC)	Conforms to reference standard	Confirmed
Melting Point	155–162°C	158°C
Loss on Drying	≤0.5%	0.2%
Residue on Ignition	≤0.1%	0.05%
Related Substances	Within specification	Pass
Heavy Metals	≤10 ppm	Compliant
Residual Solvents	Within specification	Pass
Sterility (injectable grade)	Sterile	Compliant
Bacterial Endotoxins (injectable grade)	≤0.5 EU/mg	Compliant

What Quality Control Tests Are Performed for Indomethacin Powder?

Each batch undergoes multi-step quality control before release to verify identity, purity and key quality attributes.

Raw Material QC → In-Process Control → HPLC Assay → IR Identity Verification → Melting Point Determination → Loss on Drying → Residue on Ignition → Related Substances (HPLC) → Heavy Metals → Residual Solvents → Sterility Test (injectable grade) → Bacterial Endotoxin Test (LAL, injectable grade) → Final Batch Release

Key evaluations include HPLC assay (≥98%), IR identity, melting point, loss on drying, residue on ignition, related substances, heavy metals, residual solvents, and for injectable grade: sterility and bacterial endotoxin (LAL) testing. Every commercial batch is supported by a batch-specific COA and relevant analytical documentation for incoming QC and supplier qualification.

What Factors Affect Indomethacin Powder Bulk Price?

Indomethacin Powder bulk pricing is driven by several key factors:

Raw Material Costs: Indole derivatives and p-chlorobenzoyl chloride starting materials directly influence manufacturing expenses.
Purity & Grade: Injectable grade (sterile, endotoxin-controlled, ≥98%) commands a significant premium over oral/technical grade.
Sterility & Endotoxin Specification: Aseptic processing and LAL-tested batches for injection carry higher production costs.
Regulatory Compliance & Certification: GMP-standard API with DMF/CEP and consistent COA demands a higher price.
Order Volume: Large-scale pharmaceutical contracts receive steeper per-kilogram discounts.
Logistics & Geography: Light-protected / moisture-proof packaging and customs compliance add to the landed cost.

Contact HDM BIO for a current quotation and volume-based pricing.

Why Choose HDM BIO as Your Indomethacin Powder Supplier?

High-purity (≥98% / typical 99%) potent NSAID API for capsule, tablet, suppository, injectable and topical formulations
Verified consistent melting point, low related substances and reliable quality
Non-selective COX inhibitor with dual COX + phospholipase A2 inhibition, classic research reference compound
GMP-aligned production, ISO & HACCP certified quality system
Full batch traceability and complete documentation (COA, MSDS, HPLC, sterility, LAL)
Flexible supply: kilogram samples to ton-level bulk API orders
Global export to 70+ countries with full customs support

Bulk Packaging, Shipping & Storage

Packaging: Foil bags for samples and moisture-proof fiber drums for bulk orders.
Custom Packaging: OEM labeling available.
Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
Storage: Store tightly sealed in a cool, dry, light-protected environment. Shelf life: 24 months.
Handling: For pharmaceutical/veterinary raw material use only; not for direct clinical administration.

Frequently Asked Questions About Indomethacin Powder

Q1: What is Indomethacin Powder?

A: Indomethacin is a potent non-steroidal anti-inflammatory drug (NSAID) of the indole-acetic acid class. It is a non-selective COX inhibitor (COX-1 IC50 740 nM, COX-2 IC50 970 nM) that also inhibits phospholipase A2. By reducing prostaglandin synthesis, it exerts strong anti-inflammatory, analgesic and antipyretic effects. Used for rheumatoid arthritis, gout, pain, fever and neonatal PDA. It has a narrow therapeutic index with high GI toxicity.

Q2: What is the CAS number?

A: 53-86-1.

Q3: How does indomethacin work?

A: It non-selectively inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis at inflammatory sites - decreasing vasodilation, edema, pain and fever. It also inhibits phospholipase A2. Because it inhibits constitutive COX-1 (GI mucosal protection, renal autoregulation, platelet function), it causes high rates of GI ulceration, renal impairment and bleeding.

Q4: What is indomethacin used for?

A: Human: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, postoperative pain, fever, neonatal PDA closure. Veterinary/research: classic reference compound for inflammation, pain and fever models; horses (with caution); birds (occasional); dogs NOT recommended for routine use due to severe GI toxicity at therapeutic doses. Also used in amyloidosis (TTR/Aβ) research.

Q5: What documents are provided with each batch?

A: Batch-specific COA, HPLC assay report, IR identity, melting point, loss on drying, residue on ignition, related substances, heavy metals, residual solvents, and for injectable grade: sterility and LAL endotoxin results, MSDS/SDS.

Q6: What purity do you supply?

A: Standard ≥98.0% HPLC; typical batch result 99%. Injectable grade with sterility and endotoxin specification available on request.

Q7: Where can I buy it from China?

A: HDM BIO supplies bulk Indomethacin Powder with batch COA and global export support.

Q8: How much does Indomethacin Powder cost?

A: Bulk pricing depends on raw material costs, purity/grade (oral vs injectable), sterility/endotoxin specification, regulatory compliance, order volume and logistics. Contact HDM BIO for a current quotation.

Q9: Are there any safety concerns?

A: Narrow therapeutic index with significant toxicity risk. GI (most serious): ulceration, bleeding, hematemesis, melena, perforation - dogs may develop severe GI injury at therapeutic doses. Renal: papillary necrosis, acute renal failure (higher risk in dehydration). Hepatic: elevated enzymes, hepatitis. Hematologic: platelet dysfunction, rare aplastic anemia. CNS: headache, dizziness, ataxia. Contraindications: active GI ulcer, severe renal/hepatic impairment, NSAID allergy, bleeding disorders, late pregnancy. Avoid combining with other NSAIDs, corticosteroids or anticoagulants. Not for direct clinical administration.

Q10: Is indomethacin safe for dogs?

A: No - not recommended for routine canine use. The MSD Veterinary Manual states indomethacin is highly toxic to the canine GI tract, causing severe ulceration, hematemesis and melena even at therapeutic doses. Use safer veterinary-approved NSAIDs (carprofen, meloxicam, firocoxib, grapiprant) instead.