This benzothiazine intermediate is a synthesis intermediate and specified impurity for both Piroxicam and Meloxicam, two oxicam-class NSAIDs used to manage pain and inflammation in conditions such as osteoarthritis and rheumatoid arthritis. Kodel Life manufactures it under ISO 9001:2015 controls, with documented process validation and batch traceability.
Piroxicam and Meloxicam are two different oxicam-class NSAIDs, but their synthesis routes converge on the same benzothiazine building block, sold under two different pharmacopoeial impurity names depending on which drug it is destined for.
At Kodel Life, we produce this intermediate in IP, BP, USP, and EP grades with a monthly output of 20 MT. Our manufacturing plant operates under ISO 9001:2015 certification and supplies to pharmaceutical companies in 21 countries across 5 continents.
This page covers everything a pharma buyer, formulator, or procurement head needs to know before sourcing this intermediate, whichever drug name they know it by.
What Is Meloxicam EP Impurity F / Piroxicam EP Impurity L?
Chemical Profile & Synonyms
Chemically, this compound is isopropyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide. Because it shares a benzothiazine core with both Piroxicam and Meloxicam, the same CAS 118854-48-1 batch serves both API synthesis routes, which is why suppliers list it under either drug name.
Meloxicam Related Compound C, Piroxicam Impurity L
Application
Impurity / synthesis intermediate
Pharmacopoeial Grades
IP, BP, USP, EP
One CAS Number, Two NSAID Synthesis Routes
A real-world example of this: a Meloxicam manufacturer and a Piroxicam manufacturer can source the identical CAS 118854-48-1 batch, since the compound functions as a synthesis intermediate and impurity reference for both oxicam-class NSAIDs.
In Piroxicam manufacturing it is tracked as Piroxicam EP Impurity L; in Meloxicam manufacturing, the same molecule is designated Meloxicam EP Impurity F, or Meloxicam Related Compound C in some USP listings.
Where This Intermediate Sits in the Synthesis Route
A quick map of how Meloxicam EP Impurity F / Piroxicam EP Impurity L moves from raw feedstock to finished therapy, so you can confirm this is the stage you actually need before ordering.
Piroxicam and Meloxicam both sit in a therapeutic category with durable, non-seasonal demand.
Osteoarthritis and inflammatory joint conditions remain among the most common chronic conditions treated worldwide
Both drugs are on national essential-medicines lists in multiple export markets Kodel Life serves
Generic NSAID formulation volumes continue to grow in price-sensitive emerging markets
Long-established safety and dosing profiles keep both molecules in active formulary use
India manufactures over 20% of the world's generic APIs and intermediates by volume. Sharing one intermediate across two finished-drug programs is a common efficiency in Indian API supply chains, and this compound is a clear example of it.
Meloxicam EP Impurity F / Piroxicam EP Impurity L Technical Specifications
Grades Available: IP, BP, USP, EP
Procurement teams sourcing Meloxicam EP Impurity F / Piroxicam EP Impurity L for regulated markets need the right pharmacopoeial grade. Here is what each covers:
IP
Indian Pharmacopoeia
Required for products marketed in India and several South Asian and African markets.
BP
British Pharmacopoeia
Accepted across the UK, the Commonwealth, and many EU countries.
USP
United States Pharmacopeia
Mandatory for products entering the US market and many Latin American regulators.
EP
European Pharmacopoeia
Required for EU market access; often accepted alongside BP.
Kodel Life supplies all four grades from a single manufacturing facility, which reduces sourcing complexity for exporters managing multi-market compliance.
Pharmacopoeial Standards & Purity
Every batch of Meloxicam EP Impurity F / Piroxicam EP Impurity L we release undergoes testing per pharmacopoeial specifications, including:
Assay (HPLC) against the applicable pharmacopoeial limit
Related substances and impurity profiling
Residual solvents (ICH Q3C Class 2 and 3)
Heavy metals and elemental impurities (ICH Q3D)
Particle size distribution
Water content by Karl Fischer titration
Certificate of Analysis (COA), technical specifications, and regulatory documentation support are available upon request. Documentation availability may vary depending on the destination market and regulatory requirements.
Packaging, Storage & Handling
Packaging
Double-lined HDPE drums with moisture-proof inner lining, typical of Kodel Life's other bulk intermediates. Exact pack size is confirmed at quotation.
Storage
Cool, dry place away from direct light. Recommended temperature below 25°C.
Shelf Life
Confirmed on the Certificate of Analysis for each batch; consistent with the storage conditions above.
Transport classification and export documentation, including COA and MSDS, are confirmed with each shipment.
Why Buyers Choose Kodel Life for Meloxicam EP Impurity F / Piroxicam EP Impurity L
Pharmaceutical companies sourcing this intermediate need more than competitive pricing. They need consistent quality, reliable documentation, and dependable supply continuity.
Manufacturing capacity of 20 MT per month
Available in IP, BP, USP, and EP grades
ISO 9001:2015 certified quality management system
Batch-specific Certificate of Analysis (COA)
Consistent isomeric purity control between batches
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
Documentation support available for qualified buyers
Why Source Meloxicam EP Impurity F / Piroxicam EP Impurity L from India?
India accounts for a significant share of global intermediate and API exports, and the reasons are structural rather than coincidental.
Regulatory Infrastructure
India has the second-highest number of US FDA-approved manufacturing sites outside the US.
Cost Advantage
Labor, raw material, and utility costs in India remain significantly lower than in Europe or North America without compromising output quality.
Scale
Large Indian manufacturers can handle multi-tonne monthly orders with consistent batch-to-batch quality.
Speed to Market
Established logistics corridors from JNPT, Mundra, and Chennai ports reduce lead times for global buyers.
Documentation Readiness
Leading intermediate and API manufacturers often maintain regulatory documentation such as DMFs, ASMFs, CEPs, or market-specific dossiers depending on their target export markets.
For buyers in the US, EU, Southeast Asia, or Africa sourcing an intermediate supplier for export, India-based manufacturers offer the most practical combination of price, scale, and compliance.
Where Meloxicam EP Impurity F / Piroxicam EP Impurity L Is Used Downstream
This intermediate feeds more than one finished API, depending on the acid or synthesis step a manufacturer applies next.
Piroxicam API
Kodel Life carries this intermediate, tracked as Piroxicam EP Impurity L, forward into its own commercial Piroxicam API line, one of five APIs currently in production.
Meloxicam API
Under the name Meloxicam EP Impurity F, the same batch is supplied to Meloxicam API manufacturers elsewhere; Kodel Life does not currently manufacture finished Meloxicam API itself.
Explore Related Manufacturing Capabilities
In addition to this intermediate, Kodel Life supports pharmaceutical companies through a broad range of manufacturing and documentation services.
API Manufacturing Services
Intermediates Supply at Scale
Quality Control & Testing
Export Documentation Support
Pharmaceutical Contract Manufacturing
Comparing Meloxicam EP Impurity F / Piroxicam EP Impurity L Suppliers: What Actually Matters
Not every intermediate supplier will fit every buyer's situation. Here is a practical comparison of the key variables:
Factor
What to Check
Why It Matters
Certifications
ISO 9001, FDA compliance, EDQM CEP
Determines which regulated markets you can sell into
Documentation Availability
COA with every batch; DMF/CEP reference where applicable
Needed if your own API filing references this intermediate
Production Capacity
MT per month, surge capacity
Avoids supply disruptions during peak demand
Grades Offered
IP / BP / USP / EP
Must match your target market's pharmacopoeial requirements
Lead Time
Standard and expedited timelines
Affects planning cycles and inventory management
Synonym Accuracy
CAS number matched to every trade name used
Prevents ordering the wrong impurity or intermediate by mistake
Export Track Record
Countries served, logistics partners
Reduces risk of first-shipment compliance issues
Kodel Life checks every box in this table. We have been exporting to 21 countries and maintain active documentation for all four pharmacopoeial grades.
What to Look for When Choosing a Meloxicam EP Impurity F / Piroxicam EP Impurity L Manufacturer
Certifications: ISO, FDA, EDQM
A certificate is only as good as the audit trail behind it. When evaluating any intermediate manufacturer, ask specifically for:
ISO 9001:2015 scope certificate covering this specific intermediate line
FDA establishment registration number (verifiable on FDA.gov)
EDQM CEP (Certificate of Suitability) if you target European markets
Kodel Life holds ISO 9001:2015 certification and follows documented quality management systems designed to support pharmaceutical intermediate manufacturing. Product documentation, including COA and technical specifications, is available to qualified buyers upon request.
COA & Documentation Availability
A Drug Master File (DMF) is a submission to a regulatory authority (USFDA, EMA, PMDA) that contains confidential details about the manufacturing process, facilities, and controls behind a drug substance or key intermediate. Buyers planning US or EU market launches should confirm whether their supplier's documentation can be referenced in a New Drug Application or Abbreviated New Drug Application.
At Kodel Life, COA and DMF-linked documentation is available upon request for qualified buyers. Our team supports the technical transfer process from the first enquiry.
Production Capacity & Lead Times
20 MT/Month
Meloxicam EP Impurity F / Piroxicam EP Impurity L production capacity
62 MT/Month
Total capacity across all products
2–4 Weeks
Standard lead time for stocked material
Custom batch orders take 6 to 8 weeks depending on specifications.
Common Mistakes Pharma Buyers Make When Sourcing Meloxicam EP Impurity F / Piroxicam EP Impurity L
1
Assuming the two drug names mean two different products
Meloxicam EP Impurity F and Piroxicam EP Impurity L are the same CAS 118854-48-1 compound. Ordering under either name gets you the identical specification.
2
Not confirming which downstream API you're filing for
Reference the correct pharmacopoeial impurity name (Meloxicam EP Impurity F vs. Piroxicam Impurity L) in your own documentation to match your regulator's expected terminology.
3
Not confirming the grade before ordering
An IP-grade intermediate cannot support a US ANDA filing. Always map the grade to your regulatory target market before placing an order.
4
Skipping isomeric purity checks
Ask for the related-substances data on the COA, not just the headline assay, since isomeric drift is the most common quality issue with shared intermediates like this one.
5
Assuming Kodel Life sells finished Meloxicam API
Kodel Life supplies this intermediate for Meloxicam synthesis but currently manufactures Piroxicam, not Meloxicam, as a finished API. Confirm which product you need before ordering.
Get Meloxicam EP Impurity F / Piroxicam EP Impurity L Samples & Pricing
If you are sourcing Meloxicam EP Impurity F / Piroxicam EP Impurity L in bulk for formulation, further synthesis, or export, our team can walk you through grade options, documentation packages, and dispatch timelines. Whether you need one tonne or twenty, the process starts the same way: a conversation with our technical sales team.
Samples
Available for pre-qualified buyers
COA / DMF
Available upon formal inquiry
20 MT/Month
Meloxicam EP Impurity F / Piroxicam EP Impurity L capacity
21 Countries
USA, UK, EU, Africa, SEA
Reach out through the enquiry form or contact us directly. We respond within 1 to 2 business days.
Interested in This Product?
Contact our team to discuss pricing, availability, and custom requirements.
Quality Certifications
ISO 9001:2015
Quality Management System
FDA Compliant
Regulatory Compliance
Why Buyers Choose Kodel Life
Manufacturing capacity of 20 MT per month
Available in IP, BP, USP, and EP grades
ISO 9001:2015 certified quality management system
Batch-specific Certificate of Analysis (COA)
Consistent isomeric purity control between batches
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
It is used as a synthesis intermediate and impurity reference compound for both Piroxicam and Meloxicam, two oxicam-class NSAIDs used to manage pain and inflammation.
Yes. Both names refer to the same compound, CAS 118854-48-1, because it appears as a synthesis intermediate and impurity marker in the manufacturing routes of both drugs.
C13H15NO5S, with a molecular weight of 297.33 g/mol.
Kodel Life supplies this intermediate at IP, BP, USP, and EP grade.
20 MT per month.
No. Kodel Life supplies this shared intermediate for Meloxicam manufacturing, but its own commercial API portfolio currently includes Piroxicam, not Meloxicam.
Yes. Every batch ships with a Certificate of Analysis, and Drug Master File access is available on request for qualified buyers.
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