Metoprolol Epoxide is the epoxidation-stage intermediate for Metoprolol, a selective beta-1 blocker used to treat hypertension, angina, and related cardiovascular conditions. Kodel Life manufactures it under ISO 9001:2015 controls, suitable for global API formulations with documented process validation and batch traceability.
Metoprolol Succinate and Metoprolol Tartrate, two of the world's most prescribed beta-blockers, both begin the same way: an epoxide intermediate that carries the molecule's core structure before it is split into either finished salt.
At Kodel Life, we produce Metoprolol Epoxide 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 choosing a Metoprolol Epoxide supplier.
What Is Metoprolol Epoxide?
Chemical Profile & Synonyms
Metoprolol Epoxide is an oxirane-based organic compound that forms during the epoxidation step of metoprolol synthesis. It is not dispensed to patients directly; it is carried forward as the key building block for both Metoprolol Succinate and Metoprolol Tartrate.
Parameter
Value
Generic Name
Metoprolol Epoxide
CAS Number
56718-70-8
Molecular Formula
C12H16O3
Molecular Weight
208.25 g/mol
Also Known As
Metoprolol Methoxy Epoxide Impurity, Metoprolol EP Impurity F
Application
Betablocker intermediate
Pharmacopoeial Grades
IP, BP, USP, EP
Physical Form
White to off-white crystalline solid
How It Fits Into Metoprolol Succinate and Tartrate Synthesis
Metoprolol Epoxide sits between raw starting materials and the finished beta-blocker API. Manufacturers convert it into the metoprolol free base, which is then salted with either succinic acid or tartaric acid depending on which downstream product they are producing.
Formulation chemists rely on its purity to control impurity carryover into the final drug substance, since small deviations at this stage can affect the impurity profile of the finished API.
Where This Intermediate Sits in the Synthesis Route
A quick map of how Metoprolol Epoxide moves from raw feedstock to finished therapy, so you can confirm this is the stage you actually need before ordering.
Starting Materials
Metoprolol Epoxide (this intermediate)
Metoprolol Succinate API
Extended-release, once-daily dosing
Metoprolol Tartrate API
Immediate-release dosing
Hypertension, angina & heart failure therapy
Why Demand for Metoprolol Intermediates Keeps Growing
Metoprolol has been a first-line beta-blocker for decades, and demand tracks the same forces driving global cardiovascular drug consumption.
According to WHO estimates, approximately 1.28 billion adults aged 30–79 years live with hypertension worldwide
Rising incidence of heart failure and post-myocardial-infarction management protocols that call for beta-blocker therapy
Increasing use of generic Metoprolol formulations in emerging markets
Expansion of hospital-based cardiac care in Africa, Southeast Asia, and South America
India manufactures over 20% of the world's generic APIs and intermediates by volume. Several of the largest Metoprolol intermediate manufacturers operate out of Gujarat and Maharashtra, benefiting from established chemical supply chains and skilled pharma workforces.
Metoprolol Epoxide Technical Specifications
Grades Available: IP, BP, USP, EP
Procurement teams sourcing Metoprolol Epoxide 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 Metoprolol Epoxide 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 Metoprolol Epoxide
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)
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
Consistent batch-to-batch quality control procedures
Documentation support available for qualified buyers
Why Source Metoprolol Epoxide 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 Metoprolol Epoxide Is Used Downstream
This intermediate feeds more than one finished API, depending on the acid or synthesis step a manufacturer applies next.
Metoprolol Succinate API
Kodel Life converts this intermediate into the free base, then salts it with succinic acid to produce the extended-release form used in once-daily hypertension and heart failure therapy.
Metoprolol Tartrate API
The same epoxide intermediate feeds into the immediate-release salt form, reacted with tartaric acid, used for acute dosing and titration in cardiovascular treatment.
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 Metoprolol Epoxide 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 Metoprolol Epoxide 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
Metoprolol Epoxide 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 Metoprolol Epoxide
1
Confusing similarly named metoprolol impurities
Metoprolol Epoxide (CAS 56718-70-8) is one of several metoprolol-related impurities with overlapping names. Always confirm the CAS number, not just the trade name, before ordering.
2
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.
3
Skipping supplier audits
Even for small initial orders, request a supplier self-audit questionnaire or arrange a remote audit for the intermediate line specifically, not just the finished API line.
4
Assuming an intermediate supplier stocks unlimited volume
Confirm current production capacity and lead time against your forecast before committing to a launch timeline.
5
Not asking for DMF or CEP reference letters upfront
If your API filing needs to reference this intermediate's manufacturing route, clarify documentation support before placing the first order.
Get Metoprolol Epoxide Samples & Pricing
If you are sourcing Metoprolol Epoxide 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
Metoprolol Epoxide 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)
Export supply experience across multiple international markets
Technical support for formulation and procurement teams
Consistent batch-to-batch quality control procedures
Metoprolol Epoxide is used as a chemical intermediate in the manufacture of Metoprolol Succinate and Metoprolol Tartrate, two beta-blocker APIs prescribed for hypertension, angina, and related cardiovascular conditions. It is not a finished drug substance.
The CAS number is 56718-70-8. Quote this number in every enquiry, purchase order, and Certificate of Analysis request to avoid confusion with related metoprolol impurities.
Yes. Metoprolol Epoxide is also referred to as Metoprolol Methoxy Epoxide Impurity and, in some pharmacopoeial listings, as Metoprolol EP Impurity F. All these names describe the same CAS 56718-70-8 compound.
Kodel Life supplies Metoprolol Epoxide at IP, BP, USP, and EP grade, so buyers can match the specification required by their target regulatory market.
Current production capacity is 20 MT per month, with scope to plan larger volumes against a confirmed forecast.
Yes. Every batch ships with a Certificate of Analysis, and Drug Master File access can be arranged on request for qualified buyers preparing regulatory filings.
Yes. Kodel Life provides samples to pre-qualified buyers for evaluation. Submit your enquiry through the contact page or the form on this page and specify your target grade and quantity.
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