Impurity Reference Standard - Products

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Cleanchem is a trusted provider of premium pharmaceutical reference materials, specializing in Pregabalin and its associated compounds. Our catalog includes pharmacopeial and non-pharmacopeial Pregabalin impurities, metabolites, nitrosamine derivatives (N-NO compounds), and stable isotope-labeled products. These reference standards play a critical role in pharmaceutical R&D, supporting activities such as product formulation, ANDA and DMF submissions, quality assurance, analytical method development, and stability assessments.
All Pregabalin-related substances undergo comprehensive characterization and are delivered with complete Certificates of Analysis and supporting analytical documentation to ensure regulatory adherence. Upon request, we can offer EP/USP traceable standards. Our products are routinely re-evaluated to maintain consistent quality and performance.

Pregabalin

CAT No: CL-PGL-01 CAS No: 148553-50-8 Mol Wt: 159.2 Mol F: C8H17NO2 Inv Status: Custom Synthesis

Chemical Name: (S)-3-(Aminomethyl)-5-methylhexanoic acid

Rac-Pregabalin

CAT No: CL-PGL-02 CAS No: 128013-69-4 Mol Wt: 159.2 Mol F: C8H17NO2 Inv Status: In Stock

Chemical Name: 3-(aminomethyl)-5-methylhexanoic acid

Pregabalin EP Impurity A

CAT No: CL-PGL-03 CAS No: 181289-23-6 Mol Wt: 141.2 Mol F: C8H15NO Inv Status: In Stock

Chemical Name: (S)-4-isobutylpyrrolidin-2-one ; (4S)-4-(2-methylpropyl) pyrrolidin-2-one

Pregabalin EP Impurity B

CAT No: CL-PGL-04 CAS No: 148553-51-9 Mol Wt: 159.2 Mol F: C8H17NO2 Inv Status: In Stock

Chemical Name: (R)-3-(aminomethyl)-5-methylhexanoic acid ; (3R)-3-(aminomethyl)-5-methylhexanoic acid (pregabalin enantiomer) ; (R)-Pregabalin

Pregabalin EP Impurity C

CAT No: CL-PGL-05 CAS No: 90-64-2 Mol Wt: 152.2 Mol F: C8H8O3 Inv Status: Custom Synthesis

Chemical Name: 2-hydroxy-2-phenylacetic acid ; (2RS)-2-Hydroxy-2-phenylacetic acid (Mandelic acid)

Pregabalin EP Impurity D

CAT No: CL-PGL-06 CAS No: 4118-51-8 Mol Wt: 194.2 Mol F: C11H14O3 Inv Status: In Stock

Chemical Name: 1-Methylethyl (2RS)-2-hydroxy-2-phenylacetate ; isopropyl 2-hydroxy-2-phenylacetate

4-Methyl-Valeraldehyde

CAT No: CL-PGL-07 CAS No: 1119-16-0 Mol Wt: 100.2 Mol F: C6H12O Inv Status: Custom Synthesis

Chemical Name: 4-Methylpentanal

4-Isobutylpyrrolidin-2-One

CAT No: CL-PGL-08 CAS No: 61312-87-6 Mol Wt: 141.2 Mol F: C8H15NO Inv Status: In Stock

Chemical Name: 4-Isobutylpyrrolidin-2-one

Pregablin RCMH Acid

CAT No: CL-PGL-09 CAS No: 181289-33-8 Mol Wt: 187.2 Mol F: C9H17NO3 Inv Status: In Stock

Chemical Name: (R)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid

Pregabalin Impurity 1

CAT No: CL-PGL-10 CAS No: 1568181-40-7 Mol Wt: 158.2 : 36.5 Mol F: C8H18N2O : HCl Inv Status: In Stock

Chemical Name: (S)-3-(Aminomethyl)-5-methylhexanamide hydrochloride

Pregabalin Impurity 2

CAT No: CL-PGL-11 CAS No: 1136478-30-2 Mol Wt: 157.2 Mol F: C8H15NO2 Inv Status: Custom Synthesis

Chemical Name: 5,6-Dehydro Pregabalin ; 3-(aminomethyl)-5-methylhex-5-enoic acid

Pregabalin Impurity 3

CAT No: CL-PGL-12 CAS No: 216576-74-8 Mol Wt: 157.2 Mol F: C8H15NO2 Inv Status: Custom Synthesis

Chemical Name: 4,5-Dehydro Pregabalin Formate ; 3-(aminomethyl)-5-methylhex-4-enoic acid

Pregabalin Impurity 4

CAT No: CL-PGL-13 CAS No: 75143-89-4 Mol Wt: 188.2 Mol F: C9H16O4 Inv Status: In Stock

Chemical Name: Pregabalin Impurity B (3-Isobutylglutaric Acid) ; 3-isobutylpentanedioic acid

Pregabalin Impurity 5

CAT No: CL-PGL-14 CAS No: 181289-15-6 Mol Wt: 187.2 Mol F: C9H17NO3 Inv Status: In Stock

Chemical Name: 3-(2-amino-2-oxoethyl)-5-methylhexanoic acid

Pregabalin Impurity 6

CAT No: CL-PGL-15 CAS No: 103011-96-7 Mol Wt: 181.2 Mol F: C10H15NO2 Inv Status: In Stock

Chemical Name: ethyl (E)-2-cyano-5-methylhex-2-enoate

Pregabalin Impurity 7

CAT No: CL-PGL-16 CAS No: 1374336-43-2 Mol Wt: 183.3 Mol F: C10H17NO2 Inv Status: Custom Synthesis

Chemical Name: (S)-1-acetyl-4-isobutylpyrrolidin-2-one

Pregabalin Impurity 8

CAT No: CL-PGL-17 CAS No: 185815-56-9 Mol Wt: 236.3 Mol F: C11H16N4O2 Inv Status: Custom Synthesis

Chemical Name: 2,4-dicyano-3-isobutylpentanediamide

Pregabalin Impurity 9

CAT No: CL-PGL-18 CAS No: 916982-10-0 Mol Wt: 169.2 Mol F: C9H15NO2 Inv Status: In Stock

Chemical Name: 4-isobutylpiperidine-2,6-dione

Pregabalin Diacid Impurity

CAT No: CL-PGL-19 CAS No: 5702-99-8 Mol Wt: 174.2 Mol F: C8H14O4 Inv Status: In Stock

Chemical Name: 2-Isobutylsuccinic acid

Pregabalin Impurity 10

CAT No: CL-PGL-20 CAS No: 181289-34-9 Mol Wt: 187.2 Mol F: C9H17NO3 Inv Status: In Stock

Chemical Name: (S)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid

Pregabalin USP Related Compound C

CAT No: CL-PGL-21 CAS No: 61312-87-6 Mol Wt: 141.2 Mol F: C8H15NO Inv Status: In Stock

Chemical Name: 4-Isobutylpyrrolidin-2-one

Pregabalin N-Formyl Impurity

CAT No: CL-PGL-23 CAS No: 1488274-42-5 Mol Wt: 187.2 Mol F: C9H17NO3 Inv Status: In Stock

Chemical Name: 3-(Formamidomethyl)-5-methylhexanoic acid

Pregabalin Amine Amide Impurity

CAT No: CL-PGL-24 CAS No: NA Mol Wt: 336.39 Mol F: C14H28N2O7 Inv Status: In Stock

Chemical Name: (S)-3-(aminomethyl)-N-N-5-trimethylhexanamide(2S),2,3-dihydroxy succinate

Pregabalin Impurity 15

CAT No: CL-PGL-25 CAS No: NA Mol Wt: 214.35 Mol F: C12H26N2O Inv Status: In Stock

Chemical Name: (S)-3-(aminomethyl)-N,N-diethyl-5-methylhexanamide

Pregablin Lactose Adduct

CAT No: CL-PGL-26 CAS No: NA Mol Wt: 465.5 Mol F: C20H35NO11 Inv Status: In Stock

Chemical Name: (S)-1-(((2R,3S,4S,5R)-2,3-Dihydroxy-5-(hydroxymethyl)-4-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydrofuran-2-yl)methyl)-4-isobutylpyrrolidin-2-one

Pregabalin Amine Amide Impurity

CAT No: CL-PGL-27 CAS No: 1026009-73-3 Mol Wt: 158.24 Mol F: C8H18N2O Inv Status: Custom Synthesis

Chemical Name: 3-(Aminomethyl)-5-methylhexanamide

Pregabalin isopropyl ester hydrochloride

CAT No: CL-PGL-28 CAS No: 1239692-16-0 Mol Wt: 201.3 Mol F: C11H23NO2:HCl Inv Status: In Stock

Chemical Name: Isopropyl (S)-3-(aminomethyl)-5-methylhexanoate hydrochloride

Pregabalin Glucose adduct

CAT No: CL-PGL-29 CAS No: NA Mol Wt: 303.25 g/mol Mol F: C14H25NO6 Inv Status: In Stock

Chemical Name: (S)-4-isobutyl-1-(((2R,3S,4R,5R)-2,3,4,5-tetrahydroxytetrahydro-2H-pyran-2-yl)methyl)pyrrolidin-2-one

Type:Impurity Reference Standard

Total Products: 28

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