Germany · Impurity Reference Standards

Impurity Reference Standards for Germany

Zemixal supplies 20,060 products from its impurity reference standards range to buyers in Germany. Locally, the main users are in basic & specialty chemicals, pharmaceuticals & generics and automotive coatings & plastics. Regular consignments go to industrial centres such as Ludwigshafen, Leverkusen / Cologne (ChemCologne) and Frankfurt-Höchst. Typical customers for this division are pharma QC and analytical development labs, regulatory affairs teams and contract research organisations.

Germany Sample products

20,060products in this division

24–30 dsea transit from India

3–5 dair freight

6categories

Supplying impurity reference standards to Germany

By sea, containers and LCL lots take roughly 24–30 days to Hamburg and Bremerhaven. Air cargo to Frankfurt (FRA) takes 3–5 days, which suits small and urgent packs. The relevant authority is BfArM / EMA. Our export desk lines up the COA, GHS SDS and shipping documents to match. 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 Germany

Authority	BfArM / EMA
Seaports	Hamburg, Bremerhaven, Wilhelmshaven
Airports	Frankfurt (FRA), Leipzig/Halle (LEJ)
Dangerous goods	IMDG by sea, IATA DGR by air

German imports follow EU REACH and CLP. A substance arriving at 1 tonne or more per year must be registered by the EU importer or by an Only Representative acting for the Indian manufacturer, and labels and SDS must be in German. Medicinal active substances require GMP compliance and an EU written confirmation, with the competent Länder authorities and BfArM overseeing authorised importers. Dangerous goods must be packed and declared under IMDG or IATA DGR, and customs needs the importer's EORI number.

From order to delivery

1–2 daysQuote and document set agreed
Price, pack sizes, Incoterm and the paperwork list are confirmed in writing.
3–7 daysPacking for export
Stock items are packed in UN-rated drums or cartons. Made-to-order material adds its own lead time.
1–3 daysExport clearance at Nhava Sheva or Mundra
Shipping bill filed, dangerous goods declared under IMDG where needed.
24–30 daysOcean transit to Hamburg
Port-to-port time depends on the vessel schedule and any transhipment.
2–5 daysImport clearance
Your broker clears the goods against local rules. Chemical oversight: ECHA (EU REACH & CLP).

Indicative total by sea: 31–47 days

By air: about 7–15 days in total.

Documents for Germany

Commercial Invoice
Packing List
Bill of Lading / Air Waybill
Certificate of Origin
Certificate of Analysis (COA)
Safety Data Sheet (16-section GHS)
REACH registration number or OR declaration (substances ≥1 t/yr)
EU Written Confirmation for API imports (Art. 46b Directive 2001/83/EC)
Dangerous Goods Declaration (IMDG/IATA) where applicable
Importer's EORI number

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 Germany

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

Full impurity reference standards range

2-(6-Bromo-hexyl)-Malonic acid diethyl ester

CAS: 6557-85-3
Formula: C₁₃H₂₃BrO₄
MW: 323.22 g/mol

ZX-022750

Salmeterol Xinafoate

CAS: 94749-08-3
Formula: C₃₆H₄₅NO₇
MW: 603.7 g/mol

ZX-022751

Salmeterol EP Impurity B

CAS: 94749-02-7
Formula: C₂₃H₃₃NO₄
MW: 387.5 g/mol

ZX-022752

Salmeterol EP Impurity C

CAS: 94749-11-8
Formula: C₂₄H₃₅NO₄
MW: 401.5 g/mol

ZX-022753

Salmeterol EP Impurity E

CAS: 108928-81-0
Formula: C₂₅H₃₇NO₄
MW: 415.6 g/mol

ZX-022754

Salmeterol USP RC H

CAS: 1330076-52-2
Formula: C₃₆H₄₃NO₆
MW: 585.7 g/mol

ZX-022755

Deoxysepiapterin

CAS: 1797-87-1
Formula: C₉H₁₁N₅O₂
MW: 221.22 g/mol

ZX-022756

L- Biopterin

CAS: 22150-76-1
Formula: C₉H₁₁N₅O₃
MW: 237.22 g/mol

ZX-022757

2-Amino-7,8-dihydropteridine-4,6(3H,5H)-dione

CAS: 1131-35-7
Formula: C₆H₇N₅O₂
MW: 181.15 g/mol

ZX-022758

Norscopolamine

CAS: 4684-28-0
Formula: C₁₆H₁₉NO₄
MW: 289.33 g/mol

ZX-022759

Selexipag Impurity D

CAS: 475084-96-9
Formula: C₂₉H₃₇N₃O₃
MW: 475.6 g/mol

ZX-022760

Selexipag Ethyl ester impurity

CAS: 2287345-22-4
Formula: C₂₇H₃₃N₃O₃
MW: 447.6 g/mol

ZX-022761

Questions

Impurity Reference Standards for Germany

Do you ship impurity standards to Germany?

Yes. We ship by sea to Hamburg and Bremerhaven, 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 Germany?

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 BfArM / EMA is agreed with you at quote stage.

How long does delivery to Germany take?

Allow 24–30 days for ocean transit or 3–5 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 Germany

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

Impurity Reference Standards in nearby countries