Romania · Impurity Reference Standards

Impurity Reference Standards for Romania

The impurity reference standards division counts 20,060 products, and each one can be quoted for delivery to Romania. Demand there comes mainly from generic pharmaceuticals & antibiotics, petroleum refining and chlor-alkali & PVC. Regular consignments go to industrial centres such as Bucharest, Iași and Cluj-Napoca. Typical customers for this division are pharma QC and analytical development labs, regulatory affairs teams and contract research organisations.

Romania Sample products

20,060products in this division

24–32 dsea transit from India

4–6 dair freight

6categories

Supplying impurity reference standards to Romania

By sea, containers and LCL lots take roughly 24–32 days to Constanța and Galați (Danube). Air cargo to Bucharest Henri Coandă (OTP) takes 4–6 days, which suits small and urgent packs. The relevant authority is ANMDMR (National Agency for Medicines and Medical Devices) / 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 Romania

Authority	ANMDMR (National Agency for Medicines and Medical Devices) / EMA
Seaports	Constanța, Galați (Danube)
Airports	Bucharest Henri Coandă (OTP), Cluj-Napoca (CLJ)
Dangerous goods	IMDG by sea, IATA DGR by air

Romania applies EU REACH and CLP. Substances imported at 1 tonne or more per year need registration by the EU importer or an Only Representative, and SDS and labels must be in Romanian. API imports require an EU written confirmation or equivalent GMP standing and an importer authorised by ANMDMR. Constanța is reached on Asia services via Suez, often with a transhipment in the eastern Mediterranean. Customs needs the importer's EORI number, and dangerous goods follow IMDG or IATA rules.

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.
24–32 daysOcean transit to Constanța
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: 31–49 days

By air: about 8–16 days in total.

Documents for Romania

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 Only Representative declaration (substances ≥1 t/yr)
SDS in REACH Annex II format in the local language (supplied to the EU importer)
EU Written Confirmation for API imports (Art. 46b Directive 2001/83/EC)
EORI number of the EU importer (customs declaration)
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 Romania

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

Full impurity reference standards range

Spectinomycin EP Impurity D

CAS: 935756-69-7
Formula: C₁₄H₂₆N₂O₈
MW: 350.36 g/mol

ZX-027007

Spectinomycin EP Impurity E

CAS: 88270-91-1
Formula: C₁₃H₂₂N₂O₇
MW: 318.32 g/mol

ZX-027008

Spectinomycin EP Impurity G (Free Base)

CAS: 1323437-07-5
Formula: C₁₄H₂₄N₂O₈
MW: 348.35 g/mol

ZX-027009

Spiramycin III

CAS: 24916-52-7
Formula: C₄₆H₇₈N₂O₁₅
MW: 899.1 g/mol

ZX-027010

Spiramycin EP Impurity H

CAS: 4617-99-6
Formula: C₃₉H₆₆N₂O₁₂
MW: 754.9 g/mol

ZX-027011

Spiramycin EP Impurity B

CAS: 249930-66-3
Formula: C₄₃H₇₆N₂O₁₄
MW: 845.1 g/mol

ZX-027012

Spiramycin EP Impurity E

CAS: 177584-14-4
Formula: C₄₃H₇₆N₂O₁₃
MW: 829.1 g/mol

ZX-027013

Spiramycin EP Impurity C

CAS: 177584-13-3
Formula: C₄₄H₇₄N₂O₁₄
MW: 855.1 g/mol

ZX-027014

Spironolactone EP Impurity F

CAS: 976-71-6
Formula: C₂₂H₂₈O₃
MW: 340.5 g/mol

ZX-027015

Spironolactone EP Impurity E

CAS: 33784-05-3
Formula: C₂₄H₃₂O₄S
MW: 416.6 g/mol

ZX-027016

Spironolactone EP Impurity C

CAS: 976-70-5
Formula: C₂₂H₃₀O₃
MW: 342.5 g/mol

ZX-027017

Spironolactone EP impurity G

CAS: 880106-10-5
Formula: C₂₄H₃₂O₅S
MW: 432.6 g/mol

ZX-027018

Questions

Impurity Reference Standards for Romania

Do you ship impurity standards to Romania?

Yes. We ship by sea to Constanța and Galați (Danube), 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 Romania?

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 ANMDMR (National Agency for Medicines and Medical Devices) / EMA is agreed with you at quote stage.

How long does delivery to Romania take?

Allow 24–32 days for ocean transit or 4–6 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 Romania

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

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