Pharmaceutical Reference

Pharmaceutical Reference Standards:
Ensuring Quality and Safety in Medicine

Pharmaceutical reference standards are critical tools that play a vital role in the quality control of medicines. These standards serve as benchmarks for the identification, purity, potency, and quality of active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). They are essential for ensuring the safety, efficacy, and consistency of drugs, which are crucial for patient health.

What are Pharmaceutical Reference Standards?

Pharmaceutical reference standards are highly purified compounds or materials that have been characterized using validated analytical methods and certified to meet specific quality attributes. These standards are typically developed and maintained by regulatory authorities, such as the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the International Pharmacopoeia (IP), as well as private organizations like the British Pharmacopoeia (BP) and the Japanese Pharmacopoeia (JP).


Pharmaceutical reference standards are used for a variety of purposes, including analytical method development, validation, and verification; testing of APIs and FDFs for identity, purity, potency, and quality; and batch-to-batch consistency testing. They are also used for calibration of instruments and equipment used in pharmaceutical analysis.

Why are Pharmaceutical Reference Standards Important?

Pharmaceutical reference standards are essential for ensuring the safety, efficacy, and consistency of drugs. They provide a common language and a standardized approach for testing and analysis of pharmaceuticals, which is critical for ensuring that drugs meet the required quality standards. They also help to identify and prevent the presence of impurities, contaminants, or adulterants in pharmaceutical products, which can be harmful to patients.


Pharmaceutical reference standards are also important for regulatory compliance. Regulatory authorities require pharmaceutical manufacturers to use validated analytical methods and reference standards to demonstrate the quality and safety of their products. Failure to comply with these requirements can result in regulatory action, such as product recall or suspension of marketing authorization.

Where to Find Pharmaceutical Reference Standards?

Pharmaceutical reference standards are available from a variety of sources, including regulatory authorities, private organizations, and commercial suppliers. The USP, EP, and IP are the primary sources of pharmaceutical reference standards in the United States, Europe, and globally, respectively. Private organizations like the BP and JP also provide reference standards for pharmaceutical analysis.


Commercial suppliers of pharmaceutical reference standards offer a wide range of products for various analytical applications. These suppliers can provide certified reference materials (CRMs) that are traceable to national or international standards and can be used for method validation and calibration of instruments and equipment.

Types of Pharmaceutical Reference Standards

Pharmaceutical reference standards can be classified into several types based on their intended use, source, and composition. Some of the common types of pharmaceutical reference standards are:

Types of Pharmaceutical Reference Standards

Pharmaceutical reference standards can be classified into several types based on their intended use, source, and composition. Some of the common types of pharmaceutical reference standards are:

  • Primary Reference Standards: These are the highest quality standards that are directly certified by a national or international pharmacopoeia. They are used as the primary standard for the calibration of instruments and as a reference material for the development and validation of analytical methods.
  • Secondary Reference Standards: These are reference standards that are traceable to primary reference standards. They are typically used as working standards for routine testing and quality control purposes.
  • In-house Reference Standards: These are reference standards that are developed and maintained by a pharmaceutical manufacturer or laboratory for internal use. They are used as a control to monitor the performance of analytical methods and to ensure the quality and consistency of the products.
  • Impurity Reference Standards: These are reference standards that are used for the identification and quantification of impurities in pharmaceutical products. They are typically used for method development and validation, as well as for routine testing.

Guidelines for Usage of Pharmaceutical Reference Standards

Pharmaceutical reference standards are critical tools for ensuring the quality and safety of medicines. To ensure their effective use, the following guidelines should be followed:

  • Select appropriate reference standards based on the intended use and analytical method.
  • Use reference standards that are traceable to national or international standards.
  • Use reference standards that have been characterized using validated analytical methods.
  • Store reference standards in appropriate conditions, as specified by the manufacturer or regulatory authority.
  • Use reference standards within their expiration date and discard expired or deteriorated standards.
  • Follow established procedures for the preparation, handling, and testing of reference standards.
  • Document the use of reference standards and maintain appropriate records
  • By following these guidelines, pharmaceutical manufacturers and laboratories can ensure the accuracy, reliability, and reproducibility of their analytical methods and products.

Conclusion Pharmaceutical reference standards are critical tools for ensuring the safety, efficacy, and consistency of drugs. They are essential for regulatory compliance and serve as a common language and standardized approach for testing and analysis of pharmaceuticals. Pharmaceutical manufacturers and laboratories should use validated analytical methods and reference standards to demonstrate the quality and safety of their products. By doing so, they can ensure that patients receive high-quality medicines that meet the required standards.

Recently Searched Impurities


Gliclazide EP Impurity F

CAS No.: 1076198-18-9
Molecular Formula: C₁₅H₂₁N₃O₃S
Molecular Weight: 323.41
CAT No.: CS-O-11092
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Isocaffeine

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Molecular Formula: C8H10N4O2
Molecular Weight: 194.2
CAT No.: CS-T-29687
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Cefadroxil impurity A

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Molecular Formula: C₈H₉NO₃
Molecular Weight: 167.16
CAT No.: CS-O-03630
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Naltrexone Aldol Dimer

CAS No.: --
Molecular Formula: C40H46N2O8
Molecular Weight: 682.80
CAT No.: CS-O-36669
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Ritonavir Impurity T

CAS No.: 869368-48-9
Molecular Formula: C₄₆H₆₆N₈O₅S₂
Molecular Weight: 875.20
CAT No.: CS-P-08105
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Cetirizine EP Impurity D Dihydrochloride

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Molecular Formula: C30H28Cl2N2
Molecular Weight: 487.5
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N-Nitrosodimethylamine (NDMA)

CAS No.: 62-75-9
Molecular Formula: C₂H₆N₂O
Molecular Weight: 74.08
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Octanoyl-L-carnitine Hcl

CAS No.: --
Molecular Formula: C₁₅H₃₁ClNO₄⁺
Molecular Weight: 324.86
CAT No.: CS-O-20090
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Atropine N-Oxide Hydrochloride

CAS No.: 4574-60-1
Molecular Formula: C₁₇H₂₄ClNO₄
Molecular Weight: 341.83
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Tolterodine USP Related Compound A

CAS No.: 124935-89-3
Molecular Formula: C₂₇H₃₇NO₅
Molecular Weight: 455.59
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Dapagliflozin Tetraacetate

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Molecular Formula: C₂₉H₃₃ClO₁₀
Molecular Weight: 577.02
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N-Nitroso-N-(phosphonomethyl)glycine

CAS No.: 56516-72-4
Molecular Formula: C₃H₇N₂O₆P
Molecular Weight: 198.07
CAT No.: CS-T-37280
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Defluoro Prasugrel Hydrochloride

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Molecular Formula: C₂₀H₂₂ClNO₃S
Molecular Weight: 391.91
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Chlorpromazine EP Impurity B DiHydrochloride

CAS No.: 19077-20-4 (free base)
Molecular Formula: C₂₁H₃₀Cl₃N₃S
Molecular Weight: 462.91
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Tetra-Pivaloyl ertugliflozin

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Molecular Formula: C42H57ClO11
Molecular Weight: 773.35
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Nimesulide EP Impurity E

CAS No.: 905858-63-1
Molecular Formula: C₁₄H₁₅NO₅S₂
Molecular Weight: 341.40 g/mol
CAT No.: CS-T-34927
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Mupirocin calcium EP impurity E sodium salt

CAS No.: 116182-44-6
Molecular Formula: C₂₆H₄₃NaO₉
Molecular Weight: 522.6
CAT No.: CS-O-11834
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Amoxicillin EP Impurity I

CAS No.: 22818-40-2
Molecular Formula: C8H9NO3
Molecular Weight: 167.16
CAT No.: CS-O-07195
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Tauro-β-muricholic Acid

CAS No.: 25696-60-0
Molecular Formula: C₂₆H₄₅NO₇S
Molecular Weight: 515.70
CAT No.: CS-T-61605
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Metamizole EP Impurity B

CAS No.: 83-07-8
Molecular Formula: C₁₁H₁₃N₃O
Molecular Weight: 203.24
CAT No.: CS-T-03236
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Rac-Cloperastine fendizoate

CAS No.: 85187-37-7
Molecular Formula: C₄₀H₃₈ClNO₅
Molecular Weight: 648.19
CAT No.: CS-L-00015
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Cortisol Impurity C ((Z)-17-deoxyaldehyde derivative)

CAS No.: 105562-13-8
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-P-07498
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Miconazole EP Impurity H

CAS No.: 181931-30-6
Molecular Formula: C₁₈H₁₆Cl₂N₂O
Molecular Weight: 347.24
CAT No.: CS-T-35630
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Mirtazapine EP Impurity F

CAS No.: 191546-97-1
Molecular Formula: C₁₇H₁₇N₃O
Molecular Weight: 279.34
CAT No.: CS-T-60029
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Tazobactam Related Compound A

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Molecular Formula: C₇H₁₂N₄O₄S
Molecular Weight: 248.26
CAT No.: CS-O-14522
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Cefazolin EP Impurity F

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Molecular Formula: C₃H₄N₄O₂
Molecular Weight: 128.09
CAT No.: CS-O-13459
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Domperidone EP Impurity B

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Molecular Formula: C₁₃H₁₄ClN₃O₂
Molecular Weight: 279.72
CAT No.: CS-O-31101
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Methotrexate EP Impurity I

CAS No.: 66147-29-3
Molecular Formula: C₂₁H₂₄N₈O₅
Molecular Weight: 468.47
CAT No.: CS-T-32161
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D-Glucosamine-6-O-sulphate

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Molecular Formula: C6H13NO9S
Molecular Weight: 277.25
CAT No.: CS-O-01579
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Pantoprazole Related Compounds D & F Mixture

CAS No.: --
Molecular Formula: C₁₇H₁₇F₂N₃O₄S+C₁₇H₁₇F₂N₃O₄S
Molecular Weight: 397.40+397.40
CAT No.: CS-O-40282
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N-nitroso Metolazone

CAS No.: --
Molecular Formula: C16H15ClN4O4S
Molecular Weight: 394.83
CAT No.: CS-O-39111
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N-Acetyl SLB

CAS No.: --
Molecular Formula: C18H17NO3
Molecular Weight: 295.33
CAT No.: CS-O-16684
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Brexpiprazole Impurity 19

CAS No.: 616227-75-9
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-P-07261
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Silodosin Impurity 2 HCl

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Molecular Formula: C₂₅H₃₁ClF₃N₃O₃
Molecular Weight: 513.98
CAT No.: CS-O-32152
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Oxaliplatin EP Impurity E

CAS No.: 82398-34-3
Molecular Formula: C₁₂H₃₀N₆O₈Pt₂
Molecular Weight: 776.56
CAT No.: CS-T-52427
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Clarithromycin EP impurity P

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Molecular Formula: C39H71NO13
Molecular Weight: 761.98
CAT No.: CS-T-53545
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Solifenacin Succinate EP Impurity G

CAS No.: 740780-79-4
Molecular Formula: C₂₃H₂₆N₂O₂
Molecular Weight: 362.46
CAT No.: CS-O-14626
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Cloxacillin EP Impurity B

CAS No.: 1642559-64-5
Molecular Formula: C₁₈H₂₀ClN₃O₄S
Molecular Weight: 409.89
CAT No.: CS-P-07449
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Puerarin

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Molecular Formula: C₂₁H₂₀O₉
Molecular Weight: 416.38
CAT No.: CS-T-60894
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Darunavir СВZ furan impurity

CAS No.: --
Molecular Formula: C₃₅H₄₃N₃O₉S
Molecular Weight: 681.80
CAT No.: CS-O-12039
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Omeprazole EP impurity F & G Mixture

CAS No.: 125656-82-8+125656-83-9
Molecular Formula: C₁₆H₁₃N₃O₂S+C₁₆H₁₃N₃O₂S
Molecular Weight: 311.36+311.36
CAT No.: CS-T-57691
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NP-DNSH

CAS No.: 851368-01-9
Molecular Formula: C₁₄H₉N₅O₈
Molecular Weight: 375.25
CAT No.: CS-O-40495
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Ibrutinib Impurity L

CAS No.: --
Molecular Formula: C50H48N12O4
Molecular Weight: 880.99 g/mol
CAT No.: CS-O-34063
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N-Desmethyl Prochlorperazine Dimaleate

CAS No.: 13500-92-0
Molecular Formula: C₂₇H₃₀ClN₃O₈S
Molecular Weight: 592.06
CAT No.: CS-T-52251
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Rac-Rasagiline benzyl impurity

CAS No.: 151252-98-1
Molecular Formula: C16H17N
Molecular Weight: 223.31
CAT No.: CS-O-46748
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Cyclosporin A Dihydro Impurity

CAS No.: 59865-15-5
Molecular Formula: C₆₂H₁₁₃N₁₁O₁₂
Molecular Weight: 1204.6
CAT No.: CS-O-07720
Stock: In-stock


N-Methylsulfonyl Nimesulide

CAS No.: 51765-72-1
Molecular Formula: C₁₄H₁₄N₂O₇S₂
Molecular Weight: 386.40
CAT No.: CS-T-34929
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Olanzapine Lactam Impurity

CAS No.: 1017241-34-7
Molecular Formula: C₁₇H₂₀N₄O₂
Molecular Weight: 312.37
CAT No.: CS-T-37864
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Buspirone EP Impurity A

CAS No.: 20980-22-7
Molecular Formula: C₈H₁₂N₄
Molecular Weight: 164.21
CAT No.: CS-O-07448
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Nebevilol Benzylated impurity

CAS No.: 929706-85-4
Molecular Formula: C₂₉H₃₁F₂NO₄
Molecular Weight: 495.56
CAT No.: CS-T-48935
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Venlafaxine N-Oxide Impurity

CAS No.: 1021933-95-8
Molecular Formula: C₁₆H₂₅NO₃
Molecular Weight: 279.37
CAT No.: CS-P-06996
Stock: In-stock


Cinacalcet Impurity B-HCl

CAS No.: 163831-65-0
Molecular Formula: C₁₉H₂₀ClN
Molecular Weight: 297.82
CAT No.: CS-O-07625
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Indapamide EP Impurity B

CAS No.: 63968-75-2
Molecular Formula: C₁₆H₁₄ClN₃O₃S
Molecular Weight: 363.82
CAT No.: CS-O-14086
Stock: In-stock


Pregnant mare serum gonadotrophin

CAS No.: 9002-70-4
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-BX-00480
Stock: In-stock


Tenofovir Alafenamide fumarate

CAS No.: 1392275-56-7
Molecular Formula: C₂₅H₃₃N₆O₉P
Molecular Weight: 592.54
CAT No.: CS-ED-01327
Stock: In-stock


Apixaban impurity A

CAS No.: 2098457-92-0
Molecular Formula: C₂₆H₂₇N₅O₄
Molecular Weight: 473.52
CAT No.: CS-AQ-00214
Stock: In-stock


penicilloic acid of cloxacillin

CAS No.: 1642629-96-6
Molecular Formula: C₁₉H₂₀ClN₃O₆S
Molecular Weight: 453.90
CAT No.: CS-O-33550
Stock: In-stock


Tridemorph (technical)

CAS No.: 81412-43-3
Molecular Formula: C7H15NO(CH2)n
Molecular Weight: 143.23
CAT No.: CS-O-43181
Stock: In-stock


N-Nitroso Midazolam EP Impurity A

CAS No.: 59469-02-2
Molecular Formula: C₁₈H₁₄ClFN₄O
Molecular Weight: 356.78
CAT No.: CS-EO-02601
Stock: In-stock


Acetohydrazide

CAS No.: 1068-57-1
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-T-00300
Stock: In-stock


Bisoprolol EP Impurity N

CAS No.: 1346601-75-9
Molecular Formula: C₁₇H₂₉NO₄
Molecular Weight: 311.42
CAT No.: CS-O-07385
Stock: In-stock


Sumatriptan EP Impurity C

CAS No.: 1797905-62-4
Molecular Formula: C₁₅H₂₃N₃O₃S
Molecular Weight: 325.43
CAT No.: CS-O-08212
Stock: In-stock


Temazepam EP Impurity F

CAS No.: 3294-96-0
Molecular Formula: C16H13CIN2O2
Molecular Weight: 300.74
CAT No.: CS-EN-00016
Stock: In-stock


N-Methyl-3-pyrrolidinyl Cyclopentylmandelate

CAS No.: 13118-11-1
Molecular Formula: C₁₈H₂₅NO₃
Molecular Weight: 303.40
CAT No.: CS-T-58556
Stock: In-stock


tert-butyl 2-((4R,6R)-6-(acetoxymethyl)-2,2- dimethyl-1,3-dioxan-4-yl)acetate

CAS No.: --
Molecular Formula: C₁₅H₂₆O₆
Molecular Weight: 302.36
CAT No.: CS-O-37832
Stock: In-stock


Thiamine Triphosphate

CAS No.: 3475-65-8
Molecular Formula: C₁₂H₁₉N₄O₁₀P₃S
Molecular Weight: 504.29
CAT No.: CS-T-87207
Stock: In-stock


Aceclofenac EP Impurity D

CAS No.: 139272-66-5
Molecular Formula: C17H15Cl2NO4
Molecular Weight: 368.21
CAT No.: CS-O-07100
Stock: In-stock


Sitagliptin EP Impurity C

CAS No.: 945261-48-3
Molecular Formula: C₁₆H₁₆F₅N₅O
Molecular Weight: 389.32
CAT No.: CS-O-08194
Stock: In-stock


Cetirizine EP Impurity E Di Hydrochloride

CAS No.: 83881-56-5
Molecular Formula: C₂₃H₃₁Cl₃N₂O₄
Molecular Weight: 505.86 g/mol
CAT No.: CS-O-07603
Stock: In-stock


Ortho Chlorambucil

CAS No.: 178481-89-5
Molecular Formula: C14H19Cl2NO2
Molecular Weight: 304.21
CAT No.: CS-O-14242
Stock: In-stock


Leflunomide EP Impurity E

CAS No.: 208401-20-1
Molecular Formula: C12H9F3N2O2
Molecular Weight: 270.21
CAT No.: CS-O-05797
Stock: In-stock


Sunitinib Impurity 1

CAS No.: 1467015-10-6
Molecular Formula: C₁₈H₁₈FN₃O₂
Molecular Weight: 327.35
CAT No.: CS-EO-01880
Stock: In-stock


Thiamine EP Impurity E

CAS No.: 299-35-4
Molecular Formula: C₁₂H₁₆N₄OS₂
Molecular Weight: 296.41
CAT No.: CS-O-31156
Stock: In-stock


Ceftazidime Delta-3-Isomer

CAS No.: --
Molecular Formula: C₂₂H₂₂N₆O₇S₂
Molecular Weight: 546.58
CAT No.: CS-O-03627
Stock: In-stock


Atenolol EP Impurity B

CAS No.: 61698-76-8
Molecular Formula: C11H15NO4
Molecular Weight: 225.2
CAT No.: CS-T-16039
Stock: In-stock


Ampicillin EP Impurity K

CAS No.: 40610-41-1
Molecular Formula: C₁₃H₁₇NO₃
Molecular Weight: 235.28
CAT No.: CS-O-07209
Stock: In-stock


Megesterol acetate Impurity I

CAS No.: --
Molecular Formula: C₂₅H₃₂O₄
Molecular Weight: 396.52
CAT No.: CS-O-11047
Stock: In-stock


Dolutegravir Enantiomer Impurity

CAS No.: 1309575-43-6
Molecular Formula: C₂₀H₁₉F₂N₃NaO₅
Molecular Weight: 442.37
CAT No.: CS-O-33105
Stock: In-stock


Tofacitinib impurity G

CAS No.: 1354486-07-9
Molecular Formula: C₁₄H₂₄Cl₂N₂
Molecular Weight: 291.26
CAT No.: CS-AQ-00037
Stock: In-stock


Ipratropium Bromide Impurity A

CAS No.: 58005-18-8
Molecular Formula: C₁₁H₂₂BrNO
Molecular Weight: 264.20
CAT No.: CS-T-56896
Stock: In-stock


Vildagliptin Impurity B

CAS No.: 1036959-23-5
Molecular Formula: C₂₄H₃₃N₅O₃
Molecular Weight: 439.55
CAT No.: CS-AQ-00079
Stock: In-stock


Artemether EP Impurity C

CAS No.: 181528-64-3
Molecular Formula: C₁₆H₂₆O₅
Molecular Weight: 298.37
CAT No.: CS-O-14323
Stock: In-stock


Timolol Related Compound C

CAS No.: 610271-57-3
Molecular Formula: C₂₃H₃₅N₇O₈S₂
Molecular Weight: 601.70
CAT No.: CS-BX-00988
Stock: In-stock


Cetirizine EP Impurity E

CAS No.: 682323-77-9
Molecular Formula: C23H29ClN2O4
Molecular Weight: 432.94
CAT No.: CS-CB-00053
Stock: In-stock


Levothyroxine Methyl Ester

CAS No.: 32180-11-3
Molecular Formula: C16H13I4NO4
Molecular Weight: 790.90
CAT No.: CS-T-44338
Stock: In-stock


Acetazolamide EP Impurity A

CAS No.: 60320-32-3
Molecular Formula: C₄H₄ClN₃OS
Molecular Weight: 177.61
CAT No.: CS-O-07109
Stock: In-stock


Carvedilol Impurity D HCl salt

CAS No.: 1391052-16-6 (Free base)
Molecular Formula: C₃₉H₄₀ClN₃O₆
Molecular Weight: 682.20
CAT No.: CS-O-16316
Stock: In-stock


Barbituric Acid

CAS No.: 67-52-7
Molecular Formula: C₄H₄N₂O₃
Molecular Weight: 128.09
CAT No.: CS-I-00067
Stock: In-stock


N,N-Diethylnicotinamide (Nikethamide)

CAS No.: 59-26-7
Molecular Formula: C₁₀H₁₄N₂O
Molecular Weight: 178.23
CAT No.: CS-T-82975
Stock: In-stock


Rocuronium Bromide EP Impurity H

CAS No.: 1190105-67-9
Molecular Formula: C₃₂H₄₉BrN₂O₄
Molecular Weight: 605.65
CAT No.: CS-T-51811
Stock: In-stock


Amisulpride EP impurity A

CAS No.: 26116-12-1
Molecular Formula: C₇H₁₆N₂
Molecular Weight: 128.22
CAT No.: CS-O-30837
Stock: In-stock


Chlorphenamine Impurity C

CAS No.: 20619-12-9
Molecular Formula: C₁₅H₁₇ClN₂
Molecular Weight: 260.76
CAT No.: CS-DH-00013
Stock: In-stock


Tigecycline (open C-ring D-ring) Quinone

CAS No.: 1268494-46-7
Molecular Formula: C₂₆H₃₂N₄O₈
Molecular Weight: 528.55
CAT No.: CS-T-62073
Stock: In-stock


Mupirocin Calcium EP Impurity H

CAS No.: --
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-O-11838
Stock: In-stock


Hyoscine Butylbromide EP Impurity E

CAS No.: --
Molecular Formula: C₂₀H₂₇NO₄
Molecular Weight: 345.43
CAT No.: CS-BX-00574
Stock: In-stock


Metoprolol EP Impurity C

CAS No.: 29122-74-5
Molecular Formula: C13H19NO3
Molecular Weight: 237.3
CAT No.: CS-T-27813
Stock: In-stock


Lenvatinib Impurity 3

CAS No.: 417724-81-3
Molecular Formula: C₁₁H₁₀N₂O₃
Molecular Weight: 218.21
CAT No.: CS-O-32796
Stock: In-stock


Valsartan EP impurity A

CAS No.: 137862-87-4
Molecular Formula: C₂₄H₂₉N₅O₃
Molecular Weight: 435.52
CAT No.: CS-O-08393
Stock: In-stock


Lamotrigine Related Compound C

CAS No.: 252186-78-0
Molecular Formula: C₉H₆CI₂N₄O
Molecular Weight: 257.08
CAT No.: CS-T-52063
Stock: In-stock


Pilocarpine Hydrochloride EP Impurity B

CAS No.: 28406-15-7
Molecular Formula: C₁₁H₁₈N₂O₃
Molecular Weight: 226.27
CAT No.: CS-O-11935
Stock: In-stock