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Pharmacopeial Impurities (EP / USP / BP)

Isotretinoin EP Impurity B

Reference StandardAvailable on request

Isotretinoin EP Impurity B (CAS 5352-74-9) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Quotes within one business day.

Pack sizes
Isotretinoin EP Impurity B chemical structure
CAS number5352-74-9
FormulaC20H28O2
Molar mass300.4 g/mol
Physical formSolid
HS code38229090
InChIKeySHGAZHPCJJPHSC-CDMOMSTLSA-N
IUPAC name(2Z,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid

About Isotretinoin EP Impurity B

Isotretinoin EP Impurity B is supplied by Zemixal as a characterised reference material for Isotretinoin analysis. For your records (Reference Standard), the material is defined by CAS 5352-74-9, formula C20H28O2 and molar mass 300.4 g/mol. It is handled as a solid.

Where it is used

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

Handling and storage

It carries the GHS signal word Warning (H315, H319 and H335), so wear gloves and eye protection and work with good ventilation.

Order it in 10 mg, 25 mg, 50 mg and 100 mg packs or ask for a bulk quotation. You receive a certificate of analysis with characterisation data with each order. 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 B
Product nameIsotretinoin EP Impurity B
Catalogue numberZX-021903
CAS number5352-74-9
IUPAC name(2Z,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
Molecular formulaC20H28O2
Molar mass300.4 g/mol
Exact mass300.2089
GradeReference Standard
Physical formSolid
XLogP36.3
H-bond donors / acceptors1 / 2
Topological polar surface area37.3 Ų
HS code38229090
InChIKeySHGAZHPCJJPHSC-CDMOMSTLSA-N
SMILESCC1=C(C(CCC1)(C)C)/C=C/C(=C\C=C\C(=C/C(=O)O)\C)/C
PubChem CID6419708
SynonymsTretinoin EP Impurity B, Isotretinoin - Impurity B, 9-cis,13-cis-Retinoic acid, 9,13-Di-cis-retinoic acid, 9,13-Retinoic acid, 9,13-di-cis-RA, 9,13-cis-retinoic acid, (9-cis,13-cis)-Retinoic Acid, 9,13-cis-retinoate, 9-cis,13-cis-retinoate, 9,13-cis-vitamin-A-acid, 9,13-cis-vitamin-alpha-acid

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 Warning

  • H315Causes skin irritation
  • H319Causes serious eye irritation
  • H335May cause respiratory irritation

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 B
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 B

Which CAS number identifies Isotretinoin EP Impurity B?
Isotretinoin EP Impurity B is registered under CAS 5352-74-9. You may also see it listed as Tretinoin EP Impurity B, Isotretinoin - Impurity B, 9-cis,13-cis-Retinoic acid. Our catalogue number for this item is ZX-021903.
What are the formula and molar mass of Isotretinoin EP Impurity B?
For Isotretinoin EP Impurity B, its formula is C20H28O2 and its molar mass is 300.4 g/mol. The systematic (IUPAC) name is (2Z,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid. InChIKey SHGAZHPCJJPHSC-CDMOMSTLSA-N lets you match it in any structure database.
How is Isotretinoin EP Impurity B used in pharmaceutical QC?
Isotretinoin EP Impurity B 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 B?
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 B?
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 B to my country?
Yes. Because Isotretinoin EP Impurity B 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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