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United States · Impurity Reference Standards

Impurity Reference Standards shipped to United States

The impurity reference standards division counts 20,060 products, and each one can be quoted for delivery to United States. Locally, the main users are in generic pharmaceuticals, biotech & life-science research and specialty chemicals. Typical delivery points include New Jersey pharma corridor, Research Triangle (North Carolina) and Boston/Cambridge. Typical customers for this division are pharma QC and analytical development labs, regulatory affairs teams and contract research organisations.

United States Sample products
20,060products in this division
28–40 dsea transit from India
3–6 dair freight
6categories

Supplying impurity reference standards to United States

Sea freight reaches New York / New Jersey and Houston in about 28–40 days port to port. Urgent or small lots fly to New York JFK (JFK) in 3–6 days. Import compliance for this category sits with FDA (CDER), and we prepare the COA, SDS and commercial documents your broker needs. Common grades for this division are Impurity reference standard with characterisation data, Secondary / working standard, Stable-isotope labelled standard and Nitrosamine (NDSRI) standard.

Grades in this division

Impurity reference standard with characterisation dataSecondary / working standardStable-isotope labelled standardNitrosamine (NDSRI) standardMetabolite standardCustom synthesised impurity

Pharma compliance in United States

AuthorityFDA (CDER)
SeaportsNew York / New Jersey, Houston, Savannah
AirportsNew York JFK (JFK), Chicago O'Hare (ORD)
Dangerous goodsIMDG by sea, IATA DGR by air

Chemical substances imported into the US must comply with the Toxic Substances Control Act. The importer files a TSCA positive or negative certification at entry, and substances must be listed on the TSCA Inventory or be exempt. APIs for human drugs are FDA-regulated, typically supported by a Drug Master File and cGMP manufacturing, and face FDA entry review. List I and List II chemicals need DEA import registration and declarations. Ocean shipments require an ISF 10+2 filing with CBP before loading.

From order to delivery

  1. 1–2 daysQuote and document set agreed

    Price, pack sizes, Incoterm and the paperwork list are confirmed in writing.

  2. 3–7 daysPacking for export

    Stock items are packed in UN-rated drums or cartons. Made-to-order material adds its own lead time.

  3. 1–3 daysExport clearance at Nhava Sheva or Mundra

    Shipping bill filed, dangerous goods declared under IMDG where needed.

  4. 28–40 daysOcean transit to New York / New Jersey

    Port-to-port time depends on the vessel schedule and any transhipment.

  5. 2–5 daysImport clearance

    Your broker clears the goods against local rules. Chemical oversight: EPA (TSCA).

Indicative total by sea: 35–57 days

By air: about 7–16 days in total.

Documents for United States

  • Commercial Invoice
  • Packing List
  • Bill of Lading / Air Waybill
  • Certificate of Origin
  • Certificate of Analysis (COA)
  • Safety Data Sheet (16-section GHS)
  • TSCA Positive/Negative Certification (by importer)
  • ISF 10+2 filing data for ocean shipments (CBP)
  • FDA prior notice / entry data and DMF reference for APIs where applicable
  • DEA import declaration or permit for List I/II chemicals where applicable
  • Dangerous Goods Declaration (IMDG/IATA) where applicable

Categories in impurity reference standards

API Impurities 9,055Pharmacopeial Impurities (EP / USP / BP) 3,890Nitrosamine Impurities 382Stable Isotope Labelled Standards (Deuterated, 13C, 15N) 976Metabolites & Degradation Products 2,569API Reference Standards 3,188

A selection we ship to United States

A rotating sample from the division. Every product in the catalogue can be quoted for this destination.

Full impurity reference standards range
Questions

Impurity Reference Standards for United States

Can Zemixal deliver impurity reference standards to United States?
Yes. We ship by sea to New York / New Jersey and Houston, by air cargo or by express courier depending on quantity and urgency. Every lot carries a COA and a 16-section GHS SDS.
Which documents come with a impurity standards shipment to United States?
Commercial invoice, packing list, certificate of analysis and SDS as standard, plus the bill of lading or air waybill and a certificate of origin. Anything specific to FDA (CDER) is agreed with you at quote stage.
How long does delivery to United States take?
Allow 28–40 days for ocean transit or 3–6 days by air, plus packing, export clearance and import clearance. The timeline on this page shows each stage.
How is the purity of an impurity standard determined?
Purity is usually assigned by HPLC area percentage, supported by structural confirmation from NMR and mass spectrometry. Where needed, water content, residual solvents or a mass balance approach are added. The methods used and the results for your lot are listed on the certificate of analysis that comes with the vial.
Can I use your impurity standards in place of official pharmacopoeial references?
Our standards are secondary or research materials, not official pharmacopoeial references. Many laboratories use them for method development, peak identification and routine testing, and keep official references for disputes or regulatory submissions where these are mandated. Your quality system and regulator decide which reference is acceptable for each test.

Other divisions for United States

Lab Reagents Solvents (HPLC & GC) Biochemicals APIs Pharmaceutical Intermediates Inorganics & Metals Specialty Chemicals

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