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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
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
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
2,5-dichloro-N,N-dimethylbenzamide 2,5-dichloro-N,N-dimethylbenzamide 90526-01-5 C9H9Cl2NO
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N- ((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl) methyl)-N-methylmethanamine hydrochloride 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N- ((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl) methyl)-N-methylmethanamine hydrochloride C33H28ClF2N5O4S2
Labetalol EP impurity D Labetalol EP impurity D 32780-65-7 C9H13ClN2O3
ethyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate ethyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate 625115-53-9 C21H21FN8O2
2-[(4-CHLORO-2-NITROPHENYL)AMINO]-BENZOIC ACID 2-[(4-CHLORO-2-NITROPHENYL)AMINO]-BENZOIC ACID 60091-87-4 C13H9ClN2O4
4-BROMO-1-(TOLUENE-4-SULFONYL)-1,2,3,4-TETRAHYDROBENZO[B]AZEPIN-5-ONE 4-BROMO-1-(TOLUENE-4-SULFONYL)-1,2,3,4-TETRAHYDROBENZO[B]AZEPIN-5-ONE 29489-04-1 C17H16BrNO3S
Ceftriaxone Sodium impurity 4 Ceftriaxone Sodium impurity 4
Sugammadex sodium Hepta-Iodine Impurity Sugammadex sodium Hepta-Iodine Impurity
Abitrone project impurity Abitrone project impurity
105981-34-8 105981-34-8 105981-34-8 C15H22N4S
1364671-52-2 1364671-52-2 1364671-52-2 C19H19ClN6O3S
1627504-43-1 1627504-43-1 1627504-43-1 C14H14ClN7
Pramipexole Impurity Q Pramipexole Impurity Q
Aprepitant Impurity 42 Aprepitant Impurity 42 172678-47-6 C20H18F7NO2
Efinaconazole Related Impurity 13 Efinaconazole Related Impurity 13 2055912-03-1 C24H32FN5O
DexMedetoMidine IMpurity 17 DexMedetoMidine IMpurity 17
Sofosbuvir IMpurity 21 Sofosbuvir IMpurity 21 2138483-01-7 C17H17FN2O6
Moxifloxacin Impurity 1 Moxifloxacin Impurity 1
Moxifloxacin Impurity 22 Moxifloxacin Impurity 22
Linagliptin Impurity F Linagliptin Impurity F
Trelagliptin Impurity 4 Trelagliptin Impurity 4
Fudosteine Impurity 1 Fudosteine Impurity 1
Sugammadex Impurity 17 Sugammadex Impurity 17 2414905-36-3 C82H120NaO48PS7
Apixaban Impurity 28 Apixaban Impurity 28 2208275-54-9
Fluvastatin EP Impurity E Fluvastatin EP Impurity E C24H26FNO4
Oseltamivir Impurity 24 Oseltamivir Impurity 24
(3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) (3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) C38H38F2N2O5
Nettopitan impurity Nettopitan impurity
Afatinib Impurity 74 Afatinib Impurity 74 1259015-90-1 C7H13NO2
Afatinib Impurity 74 Afatinib Impurity 74 1259015-90-1 C7H13NO2
Afatinib Impurity 78 Afatinib Impurity 78
Afatinib Impurity 78 Afatinib Impurity 78
Cabozantinib Impurity 47 Cabozantinib Impurity 47 113136-79-1 C11H10ClNO3
Landiolol impurity Q Landiolol impurity Q
Tenofovir Impurity 72 Tenofovir Impurity 72
Medetomidine Impurity 52 Medetomidine Impurity 52 128366-51-8 C13H14N2O2
Fulvestrant impurity I Fulvestrant impurity I
Emtricitabine Emtricitabine 61548-81-0 C11H22O3S
tert-butyl 4-(3-nitropyridin-4-yl)piperazine-1-carboxylate tert-butyl 4-(3-nitropyridin-4-yl)piperazine-1-carboxylate 608142-93-4 C14H20N4O4
FEXOFENADINE, METHYL ESTER FEXOFENADINE, METHYL ESTER 154825-96-4 C33H41NO4
Baricitinib Impurity 1 Baricitinib Impurity 1 2964606-44-6 C15H15N7O2S
Bendamustine Related Impurity 21 Bendamustine Related Impurity 21
Bendamustine Related Impurity 8 Bendamustine Related Impurity 8
Bortezomib Impurity 33 Bortezomib Impurity 33
Moxifloxacin Impurity 31 Moxifloxacin Impurity 31
Pitavastatin Impurity 7 Pitavastatin Impurity 7
Prednisolone Impurity A Prednisolone Impurity A 77017-17-5 C21H26O5
Rivaroxaban Impurity 61 Rivaroxaban Impurity 61 1643354-27-1 C32H30N4O8
Rivaroxaban Impurity 74 Rivaroxaban Impurity 74
Sitafloxacin Impurity 6 Sitafloxacin Impurity 6
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
Thiamine EP Impurity F HCl Thiamine EP Impurity F HCl 4102-72-1 C13H19N4OS.ClH.Cl
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
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