Japan · Impurity Reference Standards

Impurity Reference Standards for Japan

The impurity reference standards division counts 20,060 products, and each one can be quoted for delivery to Japan. Locally, the main users are in pharmaceuticals, electronics & semiconductor materials and automotive. Typical delivery points include Tokyo / Kanagawa, Osaka (Doshomachi) and Toyama. Typical customers for this division are pharma QC and analytical development labs, regulatory affairs teams and contract research organisations.

Japan Sample products

20,060products in this division

20–30 dsea transit from India

3–5 dair freight

6categories

Supplying impurity reference standards to Japan

Sea freight reaches Tokyo and Yokohama in about 20–30 days port to port. Urgent or small lots fly to Tokyo Narita (NRT) in 3–5 days. Import compliance for this category sits with PMDA / MHLW, 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 Japan

Authority	PMDA / MHLW
Seaports	Tokyo, Yokohama, Kobe
Airports	Tokyo Narita (NRT), Osaka Kansai (KIX)
Dangerous goods	IMDG by sea, IATA DGR by air

New chemical substances must be notified under the Chemical Substances Control Law (CSCL), administered jointly by METI, MHLW and MOE, and importers report annual volumes of existing substances. The Industrial Safety and Health Act (ISHL) requires Japanese-language SDS and labels for listed substances, prepared by the importer. APIs need registration in the Japanese Drug Master File system with PMDA and foreign manufacturer accreditation. Dangerous goods follow IMDG or IATA rules, and CEPA preference requires a certificate of origin.

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.
20–30 daysOcean transit to Tokyo
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: METI / MHLW / MOE (CSCL), MHLW (ISHL).

Indicative total by sea: 27–47 days

By air: about 7–15 days in total.

Documents for Japan

Commercial Invoice
Packing List
Bill of Lading / Air Waybill
Certificate of Origin
Certificate of Analysis (COA)
Safety Data Sheet (16-section GHS)
CSCL existing-substance confirmation or new substance notification
Japanese-language SDS / label under ISHL (prepared by importer)
PMDA foreign manufacturer accreditation / Japanese DMF reference for APIs 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 Japan

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

Full impurity reference standards range

7-Hydroxy Mitomycin

CAS: 7041-61-4
Formula: C₁₅H₁₇N₃O₆
MW: 335.31 g/mol

ZX-030666

Mitotane

CAS: 53-19-0
Formula: C₁₄H₁₀Cl₄
MW: 320 g/mol

ZX-030667

(S)-6,7-Dimethoxy-2-methyl-1-(3,4,5-trimethoxybenzyl)-1,2,3,4-tetrahydroisoquinoline

CAS: 104758-47-6
Formula: C₂₂H₂₉NO₅
MW: 387.5 g/mol

ZX-030668

Mizolastine

CAS: 108612-45-9
Formula: C₂₄H₂₅FN₆O
MW: 432.5 g/mol

ZX-030669

Mobocertinib

CAS: 1847461-43-1
Formula: C₃₂H₃₉N₇O₄
MW: 585.7 g/mol

ZX-030670

Moexipril tert-Butyl ester maleic acid salt

CAS: 103733-40-0
Formula: C₃₅H₄₆N₂O₁₁
MW: 670.7 g/mol

ZX-030671

(S)-6,7-Dimethoxy-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid hydrochloride

CAS: 82586-62-7
Formula: C₁₂H₁₆ClNO₄
MW: 273.71 g/mol

ZX-030672

Moexipril Hydrochloride

CAS: 82586-52-5
Formula: C₂₇H₃₅ClN₂O₇
MW: 535 g/mol

ZX-030673

Moexipril USP Related Compound G

CAS: 1356841-17-2
Formula: C₂₆H₃₃ClN₂O₇
MW: 521 g/mol

ZX-030674

Molindone Hydrochloride

CAS: 15622-65-8
Formula: C₁₆H₂₅ClN₂O₂
MW: 312.83 g/mol

ZX-030675

Molindone Impurity A

CAS: 32818-79-4
Formula: C₅H₉NO₂
MW: 115.13 g/mol

ZX-030676

Molnupiravir

CAS: 2492423-29-5
Formula: C₁₃H₁₉N₃O₇
MW: 329.31 g/mol

ZX-030677

Questions

Impurity Reference Standards for Japan

Can Zemixal deliver impurity reference standards to Japan?

Yes. We ship by sea to Tokyo and Yokohama, 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 Japan?

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 PMDA / MHLW is agreed with you at quote stage.

How long does delivery to Japan take?

Allow 20–30 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 Japan

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

Impurity Reference Standards in nearby countries