ISO/IEC 17025:2017 accredited labUSFDA-registered facility40+ years in analytical testing

Impurity & Reference Standards

Pharmaceutical Impurity & Reference Standards Supplier in India

Auriga Research supplies pharmaceutical impurity standards, nitrosamine and NDSRI standards, working standards, metabolite standards and natural product standards to QC, analytical development and regulatory teams. Every standard ships with full characterisation data and a CoA, and because we are also an ISO/IEC 17025:2017 accredited testing lab, we can develop the method and run the testing too.

We are the only Indian reference-standard supplier that is also your testing lab. We synthesise the impurity, develop and validate the method that measures it, and run the routine testing of your batches, so the standard, the method and the results all come from one team.

Request a quote WhatsApp +91-7428116100

What we supply

We supply reference standards for the impurities named in your specifications, the pharmacopoeial monographs and your regulatory filings. Each card below opens a detailed page as soon as it is published.

  • Nitrosamine and NDSRI standards Small nitrosamines and drug substance-related nitrosamines for method development and routine testing.
  • Impurity standards Process impurities and degradation products named in pharmacopoeial monographs and your own specifications.
  • Working standards In-house secondary standards qualified against a primary standard for day-to-day QC use.
  • Metabolite standards Drug metabolites for bioanalytical and impurity work.
  • Natural product standards Reference standards for natural products and their marker compounds.
  • Reference materials ISO 17034 accreditation in process. This page will explain what changes for buyers once it is granted.

Supplier and testing lab in one place

The only Indian reference-standard supplier that is also your testing lab. We synthesise the impurity, develop and validate the method that measures it, and run the routine testing of your batches. You deal with one team, and the standard, the method and the results all come from the same place.

Nitrosamines show this best. Most projects need four things in sequence, and we cover all four:

  1. Risk assessment

    Find where a nitrosamine could form in your API, excipients or process.

    Nitrosamine testing

  2. NDSRI standard

    We supply the nitrosamine standard or synthesise it to order, with a CoA.

    Custom synthesis

  3. LC-MS/MS method

    Our analytical team develops and validates a method using that standard.

    Method validation

  4. Routine testing

    Your batches are tested against the validated method in the same lab.

    Nitrosamine testing

What comes with every standard

Every standard ships with a certificate of analysis (CoA) and the characterisation data behind it, so your QC or regulatory team can see how identity, purity and content were established.

Quality and accreditation

Accreditation applies to our laboratory, not to individual products. This is where we stand today.

  • ISO/IEC 17025:2017 accredited lab

    Our testing laboratory has held ISO/IEC 17025 accreditation since 2003.

  • USFDA-registered facility

    Registered with the US Food and Drug Administration.

  • 40+ years

    Analytical testing since 1985.

  • ISO 17034 accreditation in process

    We will say so here, with the certificate details, once it is granted.

How to order

  1. Send us the details

    The compound name, CAS number if known, parent API and the quantity you need, through the form below or WhatsApp.

  2. We confirm availability

    We tell you whether the standard is in stock or, if it is not, the lead time to synthesise it.

  3. You receive a quote

    Price, quantity, documentation and delivery time, in writing.

  4. Dispatch with documents

    The standard ships with its CoA, a safety data sheet (SDS) and the HS code for customs.

More detail

  • How to order What to send us, how quotes work and how standards are shipped.
  • Quality and accreditations How our standards are characterised, documented and released.

Frequently asked questions

What is the difference between a working standard, a reference standard and a certified reference material?
A reference standard is a well-characterised material used to confirm the identity, purity or content of a substance in an analytical test. A working standard is a secondary material that a lab qualifies against a reference standard and then uses for routine runs, which saves the more expensive primary material. A certified reference material (CRM) is a reference material whose certified values carry a stated uncertainty and traceability, issued by a producer accredited for that purpose. Auriga supplies qualified, fully characterised reference standards. Our own accreditation as a reference material producer is in process, so we do not describe any of our products as CRMs.
What documents come with each standard?
Every standard is supplied with a certificate of analysis (CoA) and the characterisation data behind it. For dispatch we also provide a safety data sheet (SDS) and the HS code your customs broker needs. Ask us for a sample CoA if you want to check the format before you order.
Can you supply a standard that is not in your catalogue?
Yes. If we do not hold the compound, our custom synthesis team can synthesise it to order, characterise it in our lab and supply it with the same documentation as a stocked standard. Send the name or structure, the parent API and the quantity, and we will tell you whether it is feasible and how long it will take.
Do you supply nitrosamine and NDSRI standards?
Yes, nitrosamine and NDSRI standards are a priority for us. Where the nitrosated analogue of your API is not available off the shelf, we can synthesise it, and our lab can then develop and validate the LC-MS/MS method and test your batches. Tell us the parent API and we will check what we can offer.
What is the minimum quantity I can order?
Minimum and maximum quantities depend on the compound and on whether it is in stock or synthesised to order. Tell us the quantity and unit (mg, g or kg) you need and we will confirm it in the quote.

Request a quote

Send the compound name, CAS number or parent API and the quantity you need. We will confirm availability or a lead time.

Chat on WhatsApp +91-7428116100 Or call +91-7428116100
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