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Pharmacopeial Impurities (EP / USP / BP)

Isotretinoin EP Impurity H

Reference StandardAvailable on request

Isotretinoin EP Impurity H (CAS 71748-58-8) supplier Zemixal: C20H26O3, COA and SDS with every lot, worldwide shipping. Quotes within one business day.

Pack sizes
Isotretinoin EP Impurity H chemical structure
CAS number71748-58-8
FormulaC20H26O3
Molar mass314.4 g/mol
Physical formSolid
HS code38229090
InChIKeyGGCUJPCCTQNTJF-FAOQNJJDSA-N
IUPAC name(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-3-oxocyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid

About Isotretinoin EP Impurity H

Isotretinoin EP Impurity H belongs to the Isotretinoin reference-standard family in the Zemixal catalogue. For your records (Reference Standard), the material is defined by CAS 71748-58-8, formula C20H26O3 and molar mass 314.4 g/mol. It is handled as a solid.

Use cases we see most often

  • Pharmacopeial method verification
  • Impurity profiling
  • QC release testing
  • ANDA / DMF filings

Handling and storage

Hazard communication follows GHS (Danger: H315, H319, H335 and H360). Our SDS lists exposure controls and first-aid measures.

Available as 10 mg, 25 mg, 50 mg and 100 mg. Larger or split packs can be arranged. Every shipment includes a certificate of analysis with characterisation data. Add it to your quote list and our team replies with price, lead time and shipping options within one business day.

Reference standards for Isotretinoin

See every impurity, metabolite and related compound we list for this API.

Isotretinoin standards

Typical uses

  • Pharmacopeial method verification
  • Impurity profiling
  • QC release testing
  • ANDA / DMF filings

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Isotretinoin EP Impurity H
Product nameIsotretinoin EP Impurity H
Catalogue numberZX-021898
CAS number71748-58-8
IUPAC name(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-3-oxocyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
Molecular formulaC20H26O3
Molar mass314.4 g/mol
Exact mass314.1882
GradeReference Standard
Physical formSolid
XLogP34.8
H-bond donors / acceptors1 / 3
Topological polar surface area54.4 Ų
HS code38229090
InChIKeyGGCUJPCCTQNTJF-FAOQNJJDSA-N
SMILESCC1=C(C(CCC1=O)(C)C)/C=C/C(=C/C=C/C(=C\C(=O)O)/C)/C
PubChem CID6437087
SynonymsIsotretinoin EP Impurity H (Free Base), 4-Keto 13-cis-Retinoic Acid, Isotretinoin - Impurity H, 4-Oxoisotretinoin, 13-cis-4-Oxoretinoic acid, Oxoretinoic acid, 4-Oxo-13-cis retinoic acid, Retinoic acid, 4-oxo-, 13-cis-, 4-Oxo-13-cis-retinoic acid, 4-Oxo-isotretinoin, Isotretinoin impurity H, EX-A914

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard

Signal word Danger

  • H315Causes skin irritation
  • H319Causes serious eye irritation
  • H335May cause respiratory irritation
  • H360May damage fertility or the unborn child

Precautionary statements P203, P261, P264, P264 + P265, P271, P280, P302 + P352, P304 + P340, P305 + P351 + P338, P318, P319, P321, P332 + P317, P337 + P317, P362 + P364, P403 + P233, P405, P501

Classification summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Isotretinoin EP Impurity H
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Isotretinoin EP Impurity H

Which CAS number identifies Isotretinoin EP Impurity H?
Isotretinoin EP Impurity H is registered under CAS 71748-58-8. You may also see it listed as Isotretinoin EP Impurity H (Free Base), 4-Keto 13-cis-Retinoic Acid, Isotretinoin - Impurity H. Our catalogue number for this item is ZX-021898.
What are the formula and molar mass of Isotretinoin EP Impurity H?
For Isotretinoin EP Impurity H, its formula is C20H26O3 and its molar mass is 314.4 g/mol. The systematic (IUPAC) name is (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-3-oxocyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid. InChIKey GGCUJPCCTQNTJF-FAOQNJJDSA-N lets you match it in any structure database.
How is Isotretinoin EP Impurity H used in pharmaceutical QC?
Isotretinoin EP Impurity H is a characterised reference material linked to Isotretinoin. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Isotretinoin EP Impurity H?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Isotretinoin EP Impurity H?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Isotretinoin EP Impurity H to my country?
Yes. Because Isotretinoin EP Impurity H is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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