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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
Enrofloxacin Impurity 1 Enrofloxacin Impurity 1 1128234-60-5 C19H22ClN3O3
Peramivir Impurity 20 Peramivir Impurity 20
Ambroxol Impurity 33 Ambroxol Impurity 33 199472-91-8 C13H20N2O
Bilastine Impurity 12 Bilastine Impurity 12 1638785-18-8 C30H42N4O3
Tadalafil Impurity 66 Tadalafil Impurity 66 1598416-07-9 C21H18N2O5
Peramivir Impurity 36 Peramivir Impurity 36
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
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
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
3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers) 3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers) 30078-48-9 C19H20N2O3
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
Org246653-1(RRT0.31) Org246653-1(RRT0.31)
Linagliptin impurity Linagliptin impurity
CEFMETAZOLE IMPURITY CEFMETAZOLE IMPURITY 76952-82-4 C13H16N6O5S3
Acyclovir impurity R Acyclovir impurity R
Ornidazole Impurity 7 Ornidazole Impurity 7 109620-80-6 C6H8ClN3O3
(1R,2S,5aS,6aS,7aR,8aS,10aS) (1R,2S,5aS,6aS,7aR,8aS,10aS)
(E)-8-(3,4-dihydroxystyryl) (E)-8-(3,4-dihydroxystyryl)
N,N'-((2Z,2'Z)-disulfanediylbis N,N'-((2Z,2'Z)-disulfanediylbis
Cabozantinib impurity 1DYH Cabozantinib impurity 1DYH 1621681-63-7 C28H24FN3O6
1-((2R,3R)-3-(2,3-dihydrobenzo[b] 1-((2R,3R)-3-(2,3-dihydrobenzo[b] 2137145-62-9 C23H36N2O5
Tiotropium Bromide Impurity 1 Tiotropium Bromide Impurity 1 2109037-83-2 C18H20ClNO4S2
Dofetilide Impurity A Dofetilide Impurity A
3-pentylisoindolin-1-one 3-pentylisoindolin-1-one 691863-84-0 C13H17NO
(1R,3R)-2-acetyl-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro- 1H-pyrido[3,4-b]indole-3-carboxylate (1R,3R)-2-acetyl-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro- 1H-pyrido[3,4-b]indole-3-carboxylate 1598416-05-7 C22H20N2O5
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
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
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
Sugammadex disulfide Impurity Sugammadex disulfide Impurity
Hispidulin 4'-O-β-D-glucopyranoside Hispidulin 4'-O-β-D-glucopyranoside 244285-12-9 C22H22O11
Dexmedetomidine Impurity 19 Dexmedetomidine Impurity 19
Voriconazole Impurity 18 Voriconazole Impurity 18 321588-94-7 C22H18ClF4N7O
Remdesivir impurity Remdesivir impurity 1911578-74-9 C12H14N5O7P
ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate 616201-27-5 C38H43FN2O5
Peramivir Impurity 16 Peramivir Impurity 16
Tiotropium bromide Impurity 13 Tiotropium bromide Impurity 13 1459721-06-2 C18H19NO4S2
Anastrozole Impurity I Anastrozole Impurity I
Anastrozole Impurity I Anastrozole Impurity I
Fluconazole impurity I(For Chinese Pharmacopiea) Fluconazole impurity I(For Chinese Pharmacopiea)
Rocuronium bromide diepoxide impurity Rocuronium bromide diepoxide impurity C21H30O4
2-hydroxy-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile 2-hydroxy-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile
6-Methoxykaempferol 3-O-glucoside 6-Methoxykaempferol 3-O-glucoside 63422-27-5 C22H22O12
Topiroxostat Impurity 39 Topiroxostat Impurity 39
Vonoprazan Impurity 60 Vonoprazan Impurity 60
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