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North Macedonia · Impurity Reference Standards

Impurity Standards supply to North Macedonia

Zemixal supplies 20,060 products from its impurity reference standards range to buyers in North Macedonia. Demand there comes mainly from generic pharmaceuticals, automotive catalyst manufacturing and ferronickel & metals. Regular consignments go to industrial centres such as Skopje, Štip and Kavadarci. Typical customers for this division are pharma QC and analytical development labs, regulatory affairs teams and contract research organisations.

North Macedonia Sample products
20,060products in this division
24–32 dsea transit from India
4–7 dair freight
6categories

Supplying impurity reference standards to North Macedonia

By sea, containers and LCL lots take roughly 24–32 days to Thessaloniki (via road/rail) and Durrës (via road). Air cargo to Skopje (SKP) takes 4–7 days, which suits small and urgent packs. The relevant authority is MALMED (Agency for Medicines and Medical Devices). 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 North Macedonia

AuthorityMALMED (Agency for Medicines and Medical Devices)
SeaportsThessaloniki (via road/rail), Durrës (via road)
AirportsSkopje (SKP)
Dangerous goodsIMDG by sea, IATA DGR by air

North Macedonia is an EU candidate, and its chemicals legislation largely follows REACH and CLP principles. Notification or registration is handled by the local importer, who also prepares the SDS in Macedonian. APIs and medicinal products are regulated by MALMED, which expects GMP evidence or a manufacturer authorisation. Precursor chemicals require import licences. Almost all sea cargo is discharged at Thessaloniki and moved north by road or rail, and dangerous goods must be declared under IMDG or IATA.

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. 24–32 daysOcean transit to Thessaloniki (via road/rail)

    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: Ministry of Environment and Physical Planning / Ministry of Health (chemicals law aligned with REACH/CLP).

Indicative total by sea: 31–49 days

By air: about 8–17 days in total.

Documents for North Macedonia

  • Commercial Invoice
  • Packing List
  • Bill of Lading / Air Waybill
  • Certificate of Origin
  • Certificate of Analysis (COA)
  • Safety Data Sheet (16-section GHS)
  • Macedonian-language SDS (prepared by the importer)
  • GMP certificate / manufacturer authorisation for APIs
  • Import licence for precursor chemicals where applicable
  • Dangerous Goods Declaration (IMDG/IATA) where applicable

A selection we ship to North Macedonia

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 North Macedonia

Do you ship impurity standards to North Macedonia?
Yes. We ship by sea to Thessaloniki (via road/rail) and Durrës (via road), 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 North Macedonia?
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 MALMED (Agency for Medicines and Medical Devices) is agreed with you at quote stage.
How long does delivery to North Macedonia take?
Allow 24–32 days for ocean transit or 4–7 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.

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