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Pharmacopeial Impurities (EP / USP / BP)

Pregabalin EP Impurity B

Reference StandardIn stock

Buy Pregabalin EP Impurity B (CAS 148553-51-9) from Zemixal. Lab and bulk packs, batch COA, fast global delivery. Exported from India with full paperwork.

Pack sizes
Pregabalin EP Impurity B chemical structure
CAS number148553-51-9
FormulaC8H17NO2
Molar mass159.23 g/mol
Physical formSolid
HS code38229090
InChIKeyAYXYPKUFHZROOJ-SSDOTTSWSA-N
IUPAC name(3R)-3-(aminomethyl)-5-methylhexanoic acid

About Pregabalin EP Impurity B

Pregabalin EP Impurity B is supplied by Zemixal as a characterised reference material for Pregabalin analysis. For your records (Reference Standard), the material is defined by CAS 148553-51-9, formula C8H17NO2 and molar mass 159.23 g/mol. It is handled as a solid.

Common uses in the lab and plant

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

Handling and storage

It carries the GHS signal word Danger (H318, H336 and H361), 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. 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 Pregabalin

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

Pregabalin 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 Pregabalin EP Impurity B
Product namePregabalin EP Impurity B
Catalogue numberZX-005910
CAS number148553-51-9
IUPAC name(3R)-3-(aminomethyl)-5-methylhexanoic acid
Molecular formulaC8H17NO2
Molar mass159.23 g/mol
Exact mass159.1259
GradeReference Standard
Physical formSolid
XLogP3-1.6
H-bond donors / acceptors2 / 3
Topological polar surface area63.3 Ų
HS code38229090
InChIKeyAYXYPKUFHZROOJ-SSDOTTSWSA-N
SMILESCC(C)C[C@H](CC(=O)O)CN
PubChem CID125889
Synonyms(R)-3-(Aminomethyl)-5-methylhexanoic acid, (R)-Pregabalin, ent-Pregabalin, Pregabalin, (R)-, Hexanoic acid, 3-(aminomethyl)-5-methyl-, (3R)-, Pregabalin(Renantiomer), Pregabalin (R enantiomer), Pregabalin impurity B CRS, EX-A4191, Pregabalin EP Impurity B/(R)-Pregabalin

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

Safety and GHS hazards

GHS05 Corrosive
Corrosive
GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard

Signal word Danger

  • H318Causes serious eye damage
  • H336May cause drowsiness or dizziness
  • H361Suspected of damaging fertility or the unborn child

Precautionary statements P203, P261, P264 + P265, P271, P280, P304 + P340, P305 + P354 + P338, P317, P318, P319, 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 Pregabalin 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 Pregabalin EP Impurity B

Which CAS number identifies Pregabalin EP Impurity B?
Pregabalin EP Impurity B is registered under CAS 148553-51-9. You may also see it listed as (R)-3-(Aminomethyl)-5-methylhexanoic acid, (R)-Pregabalin, ent-Pregabalin. Our catalogue number for this item is ZX-005910.
What are the formula and molar mass of Pregabalin EP Impurity B?
For Pregabalin EP Impurity B, its formula is C8H17NO2 and its molar mass is 159.23 g/mol. The systematic (IUPAC) name is (3R)-3-(aminomethyl)-5-methylhexanoic acid. InChIKey AYXYPKUFHZROOJ-SSDOTTSWSA-N lets you match it in any structure database.
How is Pregabalin EP Impurity B used in pharmaceutical QC?
Pregabalin EP Impurity B is a characterised reference material linked to Pregabalin. 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 Pregabalin 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 Pregabalin 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 Pregabalin EP Impurity B to my country?
Yes. Because Pregabalin 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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