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.
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.
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.
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.
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:
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:
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:
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.
CAS No.: 1076198-18-9
Molecular Formula: C₁₅H₂₁N₃O₃S
Molecular Weight: 323.41
CAT No.: CS-O-11092
Stock: In-stock
CAS No.: 519-32-4
Molecular Formula: C8H10N4O2
Molecular Weight: 194.2
CAT No.: CS-T-29687
Stock: In-stock
CAS No.: 22818-40-2
Molecular Formula: C₈H₉NO₃
Molecular Weight: 167.16
CAT No.: CS-O-03630
Stock: In-stock
CAS No.: --
Molecular Formula: C40H46N2O8
Molecular Weight: 682.80
CAT No.: CS-O-36669
Stock: In-stock
CAS No.: 869368-48-9
Molecular Formula: C₄₆H₆₆N₈O₅S₂
Molecular Weight: 875.20
CAT No.: CS-P-08105
Stock: In-stock
CAS No.: 856841-95-7
Molecular Formula: C30H28Cl2N2
Molecular Weight: 487.5
CAT No.: CS-O-07602
Stock: In-stock
CAS No.: 62-75-9
Molecular Formula: C₂H₆N₂O
Molecular Weight: 74.08
CAT No.: CS-T-59621
Stock: In-stock
CAS No.: --
Molecular Formula: C₁₅H₃₁ClNO₄⁺
Molecular Weight: 324.86
CAT No.: CS-O-20090
Stock: In-stock
CAS No.: 4574-60-1
Molecular Formula: C₁₇H₂₄ClNO₄
Molecular Weight: 341.83
CAT No.: CS-K-00214
Stock: In-stock
CAS No.: 124935-89-3
Molecular Formula: C₂₇H₃₇NO₅
Molecular Weight: 455.59
CAT No.: CS-T-58691
Stock: In-stock
CAS No.: 461432-25-7
Molecular Formula: C₂₉H₃₃ClO₁₀
Molecular Weight: 577.02
CAT No.: CS-T-73520
Stock: In-stock
CAS No.: 56516-72-4
Molecular Formula: C₃H₇N₂O₆P
Molecular Weight: 198.07
CAT No.: CS-T-37280
Stock: In-stock
CAS No.: 1391053-53-4
Molecular Formula: C₂₀H₂₂ClNO₃S
Molecular Weight: 391.91
CAT No.: CS-T-14782
Stock: In-stock
CAS No.: 19077-20-4 (free base)
Molecular Formula: C₂₁H₃₀Cl₃N₃S
Molecular Weight: 462.91
CAT No.: CS-P-07392
Stock: In-stock
CAS No.: 2161341-44-0
Molecular Formula: C42H57ClO11
Molecular Weight: 773.35
CAT No.: CS-O-32487
Stock: In-stock
CAS No.: 905858-63-1
Molecular Formula: C₁₄H₁₅NO₅S₂
Molecular Weight: 341.40 g/mol
CAT No.: CS-T-34927
Stock: In-stock
CAS No.: 116182-44-6
Molecular Formula: C₂₆H₄₃NaO₉
Molecular Weight: 522.6
CAT No.: CS-O-11834
Stock: In-stock
CAS No.: 22818-40-2
Molecular Formula: C8H9NO3
Molecular Weight: 167.16
CAT No.: CS-O-07195
Stock: In-stock
CAS No.: 25696-60-0
Molecular Formula: C₂₆H₄₅NO₇S
Molecular Weight: 515.70
CAT No.: CS-T-61605
Stock: In-stock
CAS No.: 83-07-8
Molecular Formula: C₁₁H₁₃N₃O
Molecular Weight: 203.24
CAT No.: CS-T-03236
Stock: In-stock
CAS No.: 85187-37-7
Molecular Formula: C₄₀H₃₈ClNO₅
Molecular Weight: 648.19
CAT No.: CS-L-00015
Stock: In-stock
CAS No.: 105562-13-8
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-P-07498
Stock: In-stock
CAS No.: 181931-30-6
Molecular Formula: C₁₈H₁₆Cl₂N₂O
Molecular Weight: 347.24
CAT No.: CS-T-35630
Stock: In-stock
CAS No.: 191546-97-1
Molecular Formula: C₁₇H₁₇N₃O
Molecular Weight: 279.34
CAT No.: CS-T-60029
Stock: In-stock
CAS No.: 118175-11-4
Molecular Formula: C₇H₁₂N₄O₄S
Molecular Weight: 248.26
CAT No.: CS-O-14522
Stock: In-stock
CAS No.: 21732-17-2
Molecular Formula: C₃H₄N₄O₂
Molecular Weight: 128.09
CAT No.: CS-O-13459
Stock: In-stock
CAS No.: 1346598-11-5
Molecular Formula: C₁₃H₁₄ClN₃O₂
Molecular Weight: 279.72
CAT No.: CS-O-31101
Stock: In-stock
CAS No.: 66147-29-3
Molecular Formula: C₂₁H₂₄N₈O₅
Molecular Weight: 468.47
CAT No.: CS-T-32161
Stock: In-stock
CAS No.: 91674-26-9
Molecular Formula: C6H13NO9S
Molecular Weight: 277.25
CAT No.: CS-O-01579
Stock: In-stock
CAS No.: --
Molecular Formula: C₁₇H₁₇F₂N₃O₄S+C₁₇H₁₇F₂N₃O₄S
Molecular Weight: 397.40+397.40
CAT No.: CS-O-40282
Stock: In-stock
CAS No.: --
Molecular Formula: C16H15ClN4O4S
Molecular Weight: 394.83
CAT No.: CS-O-39111
Stock: In-stock
CAS No.: --
Molecular Formula: C18H17NO3
Molecular Weight: 295.33
CAT No.: CS-O-16684
Stock: In-stock
CAS No.: 616227-75-9
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-P-07261
Stock: In-stock
CAS No.: 1889255-72-4
Molecular Formula: C₂₅H₃₁ClF₃N₃O₃
Molecular Weight: 513.98
CAT No.: CS-O-32152
Stock: In-stock
CAS No.: 82398-34-3
Molecular Formula: C₁₂H₃₀N₆O₈Pt₂
Molecular Weight: 776.56
CAT No.: CS-T-52427
Stock: In-stock
CAS No.: 123967-58-8
Molecular Formula: C39H71NO13
Molecular Weight: 761.98
CAT No.: CS-T-53545
Stock: In-stock
CAS No.: 740780-79-4
Molecular Formula: C₂₃H₂₆N₂O₂
Molecular Weight: 362.46
CAT No.: CS-O-14626
Stock: In-stock
CAS No.: 1642559-64-5
Molecular Formula: C₁₈H₂₀ClN₃O₄S
Molecular Weight: 409.89
CAT No.: CS-P-07449
Stock: In-stock
CAS No.: 3681-99-0
Molecular Formula: C₂₁H₂₀O₉
Molecular Weight: 416.38
CAT No.: CS-T-60894
Stock: In-stock
CAS No.: --
Molecular Formula: C₃₅H₄₃N₃O₉S
Molecular Weight: 681.80
CAT No.: CS-O-12039
Stock: In-stock
CAS No.: 125656-82-8+125656-83-9
Molecular Formula: C₁₆H₁₃N₃O₂S+C₁₆H₁₃N₃O₂S
Molecular Weight: 311.36+311.36
CAT No.: CS-T-57691
Stock: In-stock
CAS No.: 851368-01-9
Molecular Formula: C₁₄H₉N₅O₈
Molecular Weight: 375.25
CAT No.: CS-O-40495
Stock: In-stock
CAS No.: --
Molecular Formula: C50H48N12O4
Molecular Weight: 880.99 g/mol
CAT No.: CS-O-34063
Stock: In-stock
CAS No.: 13500-92-0
Molecular Formula: C₂₇H₃₀ClN₃O₈S
Molecular Weight: 592.06
CAT No.: CS-T-52251
Stock: In-stock
CAS No.: 151252-98-1
Molecular Formula: C16H17N
Molecular Weight: 223.31
CAT No.: CS-O-46748
Stock: In-stock
CAS No.: 59865-15-5
Molecular Formula: C₆₂H₁₁₃N₁₁O₁₂
Molecular Weight: 1204.6
CAT No.: CS-O-07720
Stock: In-stock
CAS No.: 51765-72-1
Molecular Formula: C₁₄H₁₄N₂O₇S₂
Molecular Weight: 386.40
CAT No.: CS-T-34929
Stock: In-stock
CAS No.: 1017241-34-7
Molecular Formula: C₁₇H₂₀N₄O₂
Molecular Weight: 312.37
CAT No.: CS-T-37864
Stock: In-stock
CAS No.: 20980-22-7
Molecular Formula: C₈H₁₂N₄
Molecular Weight: 164.21
CAT No.: CS-O-07448
Stock: In-stock
CAS No.: 929706-85-4
Molecular Formula: C₂₉H₃₁F₂NO₄
Molecular Weight: 495.56
CAT No.: CS-T-48935
Stock: In-stock
CAS No.: 1021933-95-8
Molecular Formula: C₁₆H₂₅NO₃
Molecular Weight: 279.37
CAT No.: CS-P-06996
Stock: In-stock
CAS No.: 163831-65-0
Molecular Formula: C₁₉H₂₀ClN
Molecular Weight: 297.82
CAT No.: CS-O-07625
Stock: In-stock
CAS No.: 63968-75-2
Molecular Formula: C₁₆H₁₄ClN₃O₃S
Molecular Weight: 363.82
CAT No.: CS-O-14086
Stock: In-stock
CAS No.: 9002-70-4
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-BX-00480
Stock: In-stock
CAS No.: 1392275-56-7
Molecular Formula: C₂₅H₃₃N₆O₉P
Molecular Weight: 592.54
CAT No.: CS-ED-01327
Stock: In-stock
CAS No.: 2098457-92-0
Molecular Formula: C₂₆H₂₇N₅O₄
Molecular Weight: 473.52
CAT No.: CS-AQ-00214
Stock: In-stock
CAS No.: 1642629-96-6
Molecular Formula: C₁₉H₂₀ClN₃O₆S
Molecular Weight: 453.90
CAT No.: CS-O-33550
Stock: In-stock
CAS No.: 81412-43-3
Molecular Formula: C7H15NO(CH2)n
Molecular Weight: 143.23
CAT No.: CS-O-43181
Stock: In-stock
CAS No.: 59469-02-2
Molecular Formula: C₁₈H₁₄ClFN₄O
Molecular Weight: 356.78
CAT No.: CS-EO-02601
Stock: In-stock
CAS No.: 1068-57-1
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-T-00300
Stock: In-stock
CAS No.: 1346601-75-9
Molecular Formula: C₁₇H₂₉NO₄
Molecular Weight: 311.42
CAT No.: CS-O-07385
Stock: In-stock
CAS No.: 1797905-62-4
Molecular Formula: C₁₅H₂₃N₃O₃S
Molecular Weight: 325.43
CAT No.: CS-O-08212
Stock: In-stock
CAS No.: 3294-96-0
Molecular Formula: C16H13CIN2O2
Molecular Weight: 300.74
CAT No.: CS-EN-00016
Stock: In-stock
CAS No.: 13118-11-1
Molecular Formula: C₁₈H₂₅NO₃
Molecular Weight: 303.40
CAT No.: CS-T-58556
Stock: In-stock
CAS No.: --
Molecular Formula: C₁₅H₂₆O₆
Molecular Weight: 302.36
CAT No.: CS-O-37832
Stock: In-stock
CAS No.: 3475-65-8
Molecular Formula: C₁₂H₁₉N₄O₁₀P₃S
Molecular Weight: 504.29
CAT No.: CS-T-87207
Stock: In-stock
CAS No.: 139272-66-5
Molecular Formula: C17H15Cl2NO4
Molecular Weight: 368.21
CAT No.: CS-O-07100
Stock: In-stock
CAS No.: 945261-48-3
Molecular Formula: C₁₆H₁₆F₅N₅O
Molecular Weight: 389.32
CAT No.: CS-O-08194
Stock: In-stock
CAS No.: 83881-56-5
Molecular Formula: C₂₃H₃₁Cl₃N₂O₄
Molecular Weight: 505.86 g/mol
CAT No.: CS-O-07603
Stock: In-stock
CAS No.: 178481-89-5
Molecular Formula: C14H19Cl2NO2
Molecular Weight: 304.21
CAT No.: CS-O-14242
Stock: In-stock
CAS No.: 208401-20-1
Molecular Formula: C12H9F3N2O2
Molecular Weight: 270.21
CAT No.: CS-O-05797
Stock: In-stock
CAS No.: 1467015-10-6
Molecular Formula: C₁₈H₁₈FN₃O₂
Molecular Weight: 327.35
CAT No.: CS-EO-01880
Stock: In-stock
CAS No.: 299-35-4
Molecular Formula: C₁₂H₁₆N₄OS₂
Molecular Weight: 296.41
CAT No.: CS-O-31156
Stock: In-stock
CAS No.: --
Molecular Formula: C₂₂H₂₂N₆O₇S₂
Molecular Weight: 546.58
CAT No.: CS-O-03627
Stock: In-stock
CAS No.: 61698-76-8
Molecular Formula: C11H15NO4
Molecular Weight: 225.2
CAT No.: CS-T-16039
Stock: In-stock
CAS No.: 40610-41-1
Molecular Formula: C₁₃H₁₇NO₃
Molecular Weight: 235.28
CAT No.: CS-O-07209
Stock: In-stock
CAS No.: --
Molecular Formula: C₂₅H₃₂O₄
Molecular Weight: 396.52
CAT No.: CS-O-11047
Stock: In-stock
CAS No.: 1309575-43-6
Molecular Formula: C₂₀H₁₉F₂N₃NaO₅
Molecular Weight: 442.37
CAT No.: CS-O-33105
Stock: In-stock
CAS No.: 1354486-07-9
Molecular Formula: C₁₄H₂₄Cl₂N₂
Molecular Weight: 291.26
CAT No.: CS-AQ-00037
Stock: In-stock
CAS No.: 58005-18-8
Molecular Formula: C₁₁H₂₂BrNO
Molecular Weight: 264.20
CAT No.: CS-T-56896
Stock: In-stock
CAS No.: 1036959-23-5
Molecular Formula: C₂₄H₃₃N₅O₃
Molecular Weight: 439.55
CAT No.: CS-AQ-00079
Stock: In-stock
CAS No.: 181528-64-3
Molecular Formula: C₁₆H₂₆O₅
Molecular Weight: 298.37
CAT No.: CS-O-14323
Stock: In-stock
CAS No.: 610271-57-3
Molecular Formula: C₂₃H₃₅N₇O₈S₂
Molecular Weight: 601.70
CAT No.: CS-BX-00988
Stock: In-stock
CAS No.: 682323-77-9
Molecular Formula: C23H29ClN2O4
Molecular Weight: 432.94
CAT No.: CS-CB-00053
Stock: In-stock
CAS No.: 32180-11-3
Molecular Formula: C16H13I4NO4
Molecular Weight: 790.90
CAT No.: CS-T-44338
Stock: In-stock
CAS No.: 60320-32-3
Molecular Formula: C₄H₄ClN₃OS
Molecular Weight: 177.61
CAT No.: CS-O-07109
Stock: In-stock
CAS No.: 1391052-16-6 (Free base)
Molecular Formula: C₃₉H₄₀ClN₃O₆
Molecular Weight: 682.20
CAT No.: CS-O-16316
Stock: In-stock
CAS No.: 67-52-7
Molecular Formula: C₄H₄N₂O₃
Molecular Weight: 128.09
CAT No.: CS-I-00067
Stock: In-stock
CAS No.: 59-26-7
Molecular Formula: C₁₀H₁₄N₂O
Molecular Weight: 178.23
CAT No.: CS-T-82975
Stock: In-stock
CAS No.: 1190105-67-9
Molecular Formula: C₃₂H₄₉BrN₂O₄
Molecular Weight: 605.65
CAT No.: CS-T-51811
Stock: In-stock
CAS No.: 26116-12-1
Molecular Formula: C₇H₁₆N₂
Molecular Weight: 128.22
CAT No.: CS-O-30837
Stock: In-stock
CAS No.: 20619-12-9
Molecular Formula: C₁₅H₁₇ClN₂
Molecular Weight: 260.76
CAT No.: CS-DH-00013
Stock: In-stock
CAS No.: 1268494-46-7
Molecular Formula: C₂₆H₃₂N₄O₈
Molecular Weight: 528.55
CAT No.: CS-T-62073
Stock: In-stock
CAS No.: --
Molecular Formula: --
Molecular Weight: --
CAT No.: CS-O-11838
Stock: In-stock
CAS No.: --
Molecular Formula: C₂₀H₂₇NO₄
Molecular Weight: 345.43
CAT No.: CS-BX-00574
Stock: In-stock
CAS No.: 29122-74-5
Molecular Formula: C13H19NO3
Molecular Weight: 237.3
CAT No.: CS-T-27813
Stock: In-stock
CAS No.: 417724-81-3
Molecular Formula: C₁₁H₁₀N₂O₃
Molecular Weight: 218.21
CAT No.: CS-O-32796
Stock: In-stock
CAS No.: 137862-87-4
Molecular Formula: C₂₄H₂₉N₅O₃
Molecular Weight: 435.52
CAT No.: CS-O-08393
Stock: In-stock
CAS No.: 252186-78-0
Molecular Formula: C₉H₆CI₂N₄O
Molecular Weight: 257.08
CAT No.: CS-T-52063
Stock: In-stock
CAS No.: 28406-15-7
Molecular Formula: C₁₁H₁₈N₂O₃
Molecular Weight: 226.27
CAT No.: CS-O-11935
Stock: In-stock