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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Ticagrelor Related Compound 75 Ticagrelor Related Compound 75
Ticagrelor Related Compound 93 Ticagrelor Related Compound 93 2207528-55-8 C23H28F2N6O4S
Vonoprazan Impurity 24 Vonoprazan Impurity 24 1807642-41-6 C16H14FN3O2S
Vonoprazan Impurity 35 Vonoprazan Impurity 35
Adefovir Impurity 2 Adefovir Impurity 2
Avibactam Impurity R Avibactam Impurity R
Blonanserin Impurity L Blonanserin Impurity L
Cefazolin USP Impurity E Cefazolin USP Impurity E
Exemestane Impurity 5 Exemestane Impurity 5
Medetomidine Impurity 28 Medetomidine Impurity 28 2240179-64-8 C23H28N2
Peramivir Impurity 4 Peramivir Impurity 4 229615-12-7 C15H28N4O4
Peramivir Impurity 9 Peramivir Impurity 9
PidotimodImpurity T PidotimodImpurity T
Albendazole EP Impurity J Albendazole EP Impurity J 946498-41-5 C9H7Cl2N3O2
Ibrutinib Dimer Impurity Ibrutinib Dimer Impurity 2031255-23-7 C50H48N12O4
Rifaximin EP Impurity H Rifaximin EP Impurity H 1210022-90-4 C43H51N3O12
Voriconazole (2R,3R)-Isomer Voriconazole (2R,3R)-Isomer 137234-76-5 C16H13ClF3N5O
Diquafosol Impurity 12 Diquafosol Impurity 12 694434-51-0 C18H26N4O23P4
Etoricoxib Impurity 39 Etoricoxib Impurity 39 107825-28-5 C13H17NOS2
Furosemide Impurity 7 Furosemide Impurity 7 4753-68-8 C5H8ClNO
Irinotecan Impurity 24 Irinotecan Impurity 24 802277-44-7 C13H24N2O2
Pyridoxine Impurity 12 Pyridoxine Impurity 12 58947-70-9 C8H9NO3
Thiamine Thiamine 6309-04-2 C13H20Br2N4OS
1,1'-(1,4,8,11-tetraazacyclotetradecane-1,4-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,4-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride C14H24Cl2F6N4O2
Empagliflozin Impurity 40 Empagliflozin Impurity 40
Empagliflozin Impurity 46 Empagliflozin Impurity 46
Mupirocin Impurity P/Decyl [2E,8[2S,3S(1S,2S)]]-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-Non-2-enonic Acid Ester Mupirocin Impurity P/Decyl [2E,8[2S,3S(1S,2S)]]-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-Non-2-enonic Acid Ester 153900-96-0 C27H48O7
Aprepitant Aprepitant 1242175-38-7 C20H18F7NO2
pranoprofen pranoprofen 143436-36-6 C17H19NO4
2-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]Benzonitrile 2-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]Benzonitrile 906673-30-1 C14H10BNO3
Fluconazole Impurity 5 Fluconazole Impurity 5 154534-83-5 C10H9ClF2N4O
Fexofenadine N-Oxide Fexofenadine N-Oxide 1422515-52-3 C32H39NO5
Trimetazidine Impurity 16 Trimetazidine Impurity 16 118709-62-9 C13H16O4
Ortho-Isomer of Dapagliflozin Ortho-Isomer of Dapagliflozin 2040305-05-1 C21H25ClO6
Acarbose Impurity H Acarbose Impurity H
Acarbose Impurity H Acarbose Impurity H
Chidamide-13C7 Chidamide-13C7 1348337-81-4 C24H18N4O4
Imidafenacin Related Compound 9 Imidafenacin Related Compound 9 170105-17-6 C21H21N3
Atracurium  Impurity M Atracurium Impurity M
Cefminox Sodium impurity 1 Cefminox Sodium impurity 1
Dapagliflozin Impurity 5 Dapagliflozin Impurity 5
Emtricitabine Impurity E Emtricitabine Impurity E
Furosemide Impurity 4 Furosemide Impurity 4 C12H11ClN2O5S
Pitavastatin Impurity 43 Pitavastatin Impurity 43
Tazobactam Impurity B Tazobactam Impurity B 158411-82-6 C6H11NO3S
Tirofiban Impurity E Tirofiban Impurity E
Tofacitinib Impurity 73 Tofacitinib Impurity 73
Tofacitinib Impurity 82 Tofacitinib Impurity 82
Apixaban Impurity 37 Apixaban Impurity 37
Atracurium Impurity 27 Atracurium Impurity 27
Aztreonam Impurity 3 Aztreonam Impurity 3
Aztreonam Impurity 9 Aztreonam Impurity 9
Bendamustine Impurity 24 Bendamustine Impurity 24
Bosutinib Impurity 4 Bosutinib Impurity 4 142072-71-7 C10H11NO4
(Z)-methyl 3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate (Z)-methyl 3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate 2093243-16-2 C17H13NO4
Abacavir Impurity F Abacavir Impurity F 1443421-68-8 C18H26N6O
Lenvatinib Impurity 10 Lenvatinib Impurity 10
Nifuratel Impurity 10 Nifuratel Impurity 10
Ozagrel Impurity 16 Ozagrel Impurity 16 143945-86-2 C13H12N2O2
Tofacitinib Impurity 68 Tofacitinib Impurity 68
2-(4R,6S)(6-Formyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid 2-(4R,6S)(6-Formyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid 123185-91-1 C9H14O5
5-(3-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3- carbaldehyde 5-(3-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3- carbaldehyde C16H11FN2O3S
Dapoxetine impurity Dapoxetine impurity 126113-24-4 C19H16O2
Loratadine Impurity 17 Loratadine Impurity 17 133330-72-0 C14H12ClNO
Prasugrel Impurity 11 Prasugrel Impurity 11
someprazole Impurity 19 someprazole Impurity 19 358675-51-1 C16H17N3O3S
Trelagliptin Impurity 18 Trelagliptin Impurity 18
Ropivacaine impurity Ropivacaine impurity 1786560-34-6 C12H14N2O3
N-((3-(5-methyl-3-(4-(N-propionylsulfamoyl)phenyl)isoxazol-4-yl)phenyl)sulfonyl)propionamide N-((3-(5-methyl-3-(4-(N-propionylsulfamoyl)phenyl)isoxazol-4-yl)phenyl)sulfonyl)propionamide C22H23N3O7S2
LPHE-009 LPHE-009 64471-45-0 C13H16O3
2-((chloro(3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-5- (difluoromethoxy)-1Na-benzo[d]imidazole 2-((chloro(3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-5- (difluoromethoxy)-1Na-benzo[d]imidazole
(3S,3'S)-3,3'-((((4,4'-dichloro-[1,1'-biphenyl]-3,3'-diyl)bis (methylene))bis(4,1-phenylene))bis(oxy))bis(tetrahydrofuran) (3S,3'S)-3,3'-((((4,4'-dichloro-[1,1'-biphenyl]-3,3'-diyl)bis (methylene))bis(4,1-phenylene))bis(oxy))bis(tetrahydrofuran) C34H32Cl2O4
4-(1,3,2-Dioxaborinan-2-yl)benzonitrile 4-(1,3,2-Dioxaborinan-2-yl)benzonitrile 152846-62-3 C10H10BNO2
Rasagiline Impurity 5 Mesylate Rasagiline Impurity 5 Mesylate 1312077-04-5 C13H15NO4S
Cefazolin EP Impurity L Cefazolin EP Impurity L
Cefoxitin Impurity 2 Cefoxitin Impurity 2
Clotrimazole Impurity 4 Clotrimazole Impurity 4
Dasatinib impurity 29 Dasatinib impurity 29 1417651-54-7 C21H16Cl3N7OS
Erlotinib Impurity 58 Erlotinib Impurity 58 2246399-22-2 C10H12N2O3
Lamivudine Impurity 4 Lamivudine Impurity 4
Olaparib Impurity 37 Olaparib Impurity 37
Oseltamivir Impurity 3 Oseltamivir Impurity 3
Phenylephrine Impurity 2 Phenylephrine Impurity 2 C9H13NO2
Pitavastatin Impurity 23 Pitavastatin Impurity 23 1467166-39-7 C28H28FNO4
Pregabalin Impurity 24 Pregabalin Impurity 24
Rocuronium Bromide Impurity 11 Rocuronium Bromide Impurity 11
Rocuronium Bromide Impurity 24 Rocuronium Bromide Impurity 24
Rosuvastatin EP Impurity L Rosuvastatin EP Impurity L
Timolol EP Impurity J Timolol EP Impurity J
Trimetazidine Impurity 7 Trimetazidine Impurity 7
Lincomycin sulfoxide Impurity 4 Lincomycin sulfoxide Impurity 4
Sulpiride Impurity 3 Sulpiride Impurity 3
Doxofylline iMpurity F Doxofylline iMpurity F
He pulls non-EP impurities D He pulls non-EP impurities D
R-(-)-O-DESMETHYLVENLAFAXINE R-(-)-O-DESMETHYLVENLAFAXINE 142761-11-3 C16H25NO2
MILRINONE RELATED COMPOUND A (50 MG) (1,6-DIHYDRO-2-METHYL-6-OXO(3,4'-BIPYRIDINE)-5-CAR-BOXAMIDE) MILRINONE RELATED COMPOUND A (50 MG) (1,6-DIHYDRO-2-METHYL-6-OXO(3,4'-BIPYRIDINE)-5-CAR-BOXAMIDE) 80047-24-1 C12H11N3O2
Anastrozole EP Impurity I Anastrozole EP Impurity I 120511-91-3 C15H17ClN2
Anastrozole EP Impurity I Anastrozole EP Impurity I 120511-91-3 C15H17ClN2
(2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid  (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester (2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester 389128-28-3 C18H26N2O5S
Everolimus impurity F Everolimus impurity F
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