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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
N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide N-(Methylsulfonyl)-N-(2-phenoxyphenyl)MethanesulfonaMide 905858-63-1 C14H15NO5S2
4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 4,5-Dihydro-α,3-diMethyl-5-oxo-1-phenyl-α-sulfo-1H-pyrazole-4-acetic Acid 1357477-99-6 C13H14N2O6S
tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)Methyl)benzoyl)piperazine-1-carboxylate 763114-04-1 C25H27FN4O4
1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 1H-IMidazole, 4-Methyl-1-[3-nitro-5-(trifluoroMethyl)phenyl]- 916975-92-3 C11H8F3N3O2
Edaravone iMpurity P3 Edaravone iMpurity P3 1323485-71-7 C13H16N2O4S
1-(diaminomethylidene)-3-[(2R,3R,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]urea 1-(diaminomethylidene)-3-[(2R,3R,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]urea 2508-80-7 C7H14N4O5
3-(2-amino-1-hydroxyethyl)benzene-1,2-diol 3-(2-amino-1-hydroxyethyl)benzene-1,2-diol 73660-93-2 C8H11NO3
(D-LYS16)-ACTH (1-24) (HUMAN, BOVINE, MOUSE, OVINE, PORCINE, RABBIT, RAT) (D-LYS16)-ACTH (1-24) (HUMAN, BOVINE, MOUSE, OVINE, PORCINE, RABBIT, RAT) 494750-52-6 C136H210N40O31S
3-(4-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile 3-(4-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile 641571-12-2 C12H8F3N3
7-Epi-10-oxo-docetaxel (Docetaxel Impurity D) 7-Epi-10-oxo-docetaxel (Docetaxel Impurity D) 162784-72-7 C43H51NO14
(Dimethylamino)acetaldehyde Dimethyl Acetal (Dimethylamino)acetaldehyde Dimethyl Acetal 38711-20-5 C6H15NO2
Dasatinib N-Oxide Dasatinib N-Oxide 910297-52-8 C22H26ClN7O3S
(R)-9-[2-(DIETHYLPHOSPHONOMETHOXY)PROPYL] ADENINE (R)-9-[2-(DIETHYLPHOSPHONOMETHOXY)PROPYL] ADENINE 180587-75-1 C13H22N5O4P
17-BETA-ESTRADIOL 3-METHYL ETHER 17-BETA-ESTRADIOL 3-METHYL ETHER 1474-53-9 C19H26O3
(3-CHLORO-3-PHENYL-PROPYL)-DIMETHYL-AMINE HYDROCHLORIDE (3-CHLORO-3-PHENYL-PROPYL)-DIMETHYL-AMINE HYDROCHLORIDE 79130-51-1 C11H16ClN
P-TOLYL-PROPYNOIC ACID ETHYL ESTER P-TOLYL-PROPYNOIC ACID ETHYL ESTER 52188-06-4 C12H12O2
cis-N-Methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride cis-N-Methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride 79617-89-3 C17H17Cl2N.HCl
Pseudomonic acid C Pseudomonic acid C 71980-98-8 C26H44O8
Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-amino-2-hydroxy-, methyl ester, (1S,2S,3R,4R)-, mono(trifluoroacetate) (salt) (9CI) Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-amino-2-hydroxy-, methyl ester, (1S,2S,3R,4R)-, mono(trifluoroacetate) (salt) (9CI) 357448-34-1 C17H29F3N2O6
Dobutamine Impurity 16 Dobutamine Impurity 16
Dobutamine Impurity 16 Dobutamine Impurity 16
Faropenem Impurity AB Faropenem Impurity AB
Nirmatrelvir Impurity 9 Nirmatrelvir Impurity 9
trans N-Benzyl Paroxetine trans N-Benzyl Paroxetine 105813-14-7 C26H26FNO3
Lasmiditan Impurity 10 Lasmiditan Impurity 10
Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- 2749357-07-9 C12H8ClN3O2
Odaterol Impurity 36 Odaterol Impurity 36
Odaterol Impurity 36 Odaterol Impurity 36
Odaterol Impurity 36 Odaterol Impurity 36
3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 67-30-1 C14H8I4O4
Avatrombopag Impurity 58 Avatrombopag Impurity 58
Avatrombopag Impurity 58 Avatrombopag Impurity 58
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
4-methylsulfinylbenzoate 4-methylsulfinylbenzoate 33963-58-5 C8H8O3S
Capecitabine Related Compound C Capecitabine Related Compound C
2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)- 2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)- 136470-79-6 C14H18N6O
Glycopyrrolate Erythro Isomer Glycopyrrolate Erythro Isomer 201667-20-1
1,2-Benzenedicarboxylicacid,3-(hydroxyamino)-(9CI) 1,2-Benzenedicarboxylicacid,3-(hydroxyamino)-(9CI) 202262-76-8 C8H7NO5
Oprinone Impurity 1 Oprinone Impurity 1
5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 91147-46-5 C11H10ClN5
(S)-(+)-3-HYDROXYTETRAHYDROFURAN (S)-(+)-3-HYDROXYTETRAHYDROFURAN 79107-75-8 C4H8OS
TRIBENZYLPHOSPHITE TRIBENZYLPHOSPHITE 15205-57-9 C21H21O3P
4-Chlor-3-nitro-5-sulfobenzoesure 4-Chlor-3-nitro-5-sulfobenzoesure 130262-91-8 C7H4ClNO7S
4-(4-Methylpiperazin-1-ylmethyl)benzoic acid 4-(4-Methylpiperazin-1-ylmethyl)benzoic acid 106261-48-7 C13H18N2O2
Diphenylpiperidin-4-ylmethanol hydrochloride Diphenylpiperidin-4-ylmethanol hydrochloride 1798-50-1 C18H22ClNO
2,4-DIMETHYLDIPHENYLSULFIDE 2,4-DIMETHYLDIPHENYLSULFIDE 16704-47-5 C14H14S
Dibenz[b,e]oxepin-11(6H)-one Dibenz[b,e]oxepin-11(6H)-one 4504-87-4 C14H10O2
2-CHLORO-1-(4,5-DICHLORO-2-THIENYL)ETHAN-1-ONE 2-CHLORO-1-(4,5-DICHLORO-2-THIENYL)ETHAN-1-ONE 64218-50-4 C6H3Cl3OS
(5Z,7E)-9,10-Seco-26,27-cyclo-1α,3β-dihydroxycholesta-5,7,10(19)-trien-24-one (5Z,7E)-9,10-Seco-26,27-cyclo-1α,3β-dihydroxycholesta-5,7,10(19)-trien-24-one 126860-84-2 C27H40O3
(-)-3-Demethylcolchicine (-)-3-Demethylcolchicine 7336-33-6 C21H23NO6
Cytarabine Impurity 12 Cytarabine Impurity 12 14057-18-2 C15H18N2O9
D,L-O-DesMethyl Venlafaxine-d6 D,L-O-DesMethyl Venlafaxine-d6 1062605-69-9 C16H19D6NO2
(E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester (E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester 78712-67-1 C12H13BrO2
3-Amino-2-butenoic acid 3-Amino-2-butenoic acid 21112-45-8 C4H7NO2
5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 74509-79-8 C9H19NO2
Sitagliptin EP Impurity 5 Sitagliptin EP Impurity 5
Simvastatin Impurity 6 Simvastatin Impurity 6
colocynthin colocynthin 1398-78-3 C38H54O13
Anastrozole Impurity 14 Anastrozole Impurity 14
Hesperidin methylchalcone Hesperidin methylchalcone 24292-52-2 C29H36O15
Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide 70381-75-8 C12H14BrCl2N3O2
4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 79617-95-1 C17H17Cl2N
Avatrombopag Impurity 77 Avatrombopag Impurity 77
methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate
N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity A(USP) Ertapenem Impurity A(USP)
D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- 2740644-40-8 C14H22N2O6
2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate 2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2731089-65-7 C27H34N2O6
2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one 2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one
Bumetanide Photodegradable Impurity 15 Bumetanide Photodegradable Impurity 15
Bisoprolol Impurity 48 Bisoprolol Impurity 48
4-nitro-1H-Imidazole-2-carboxaldehyde 4-nitro-1H-Imidazole-2-carboxaldehyde 33543-81-6 C4H3N3O3
1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1133-49-9 C10H13ClO3
Bumetanide Impurity 19 Bumetanide Impurity 19
Rocuronium Bromide Impurity 26 、27 Rocuronium Bromide Impurity 26 、27
Roxadustat Impurity 20 Roxadustat Impurity 20
Ruxolitinib Impurity Ruxolitinib Impurity
	Sitagliptin Impurity 82 Sitagliptin Impurity 82
(1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate (1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate
Perospirone Impurity 21 Perospirone Impurity 21
Perospirone Impurity 11 Perospirone Impurity 11
Dolutegravir Impurity 21 Dolutegravir Impurity 21
Related impurities of fluoxetine sodium 6 Related impurities of fluoxetine sodium 6
Fondaparinux sodium impurity 7 Fondaparinux sodium impurity 7
Fondaparinux sodium impurity 3 Fondaparinux sodium impurity 3
Oxacillin sodium  Impurity B Oxacillin sodium Impurity B
Revefenacin Impurity 21 Revefenacin Impurity 21
Nilotinib N-Oxide Impurity 3 Nilotinib N-Oxide Impurity 3
Amoxicillin Impurity U(EP) Amoxicillin Impurity U(EP)
Pemetrexed Impurity 51 Pemetrexed Impurity 51
6-((S)-7-amino-5-azaspiro[2.4]heptan-5-yl)-8-chloro-7-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 6-((S)-7-amino-5-azaspiro[2.4]heptan-5-yl)-8-chloro-7-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
(S)-Tamsulosin Hydrochloride (S)-Tamsulosin Hydrochloride 106463-19-8 C20H29ClN2O5S
2,2'-Bisnalmefene 2,2'-Bisnalmefene 176220-84-1 C42H48N2O6
4-Desmethoxypropoxyl-4-chloro Rabeprazole 4-Desmethoxypropoxyl-4-chloro Rabeprazole 168167-42-8 C14H12ClN3OS
N-Desmethyl-4-hydroxy Tamoxifen (approx. 1:1 E/Z Mixture) N-Desmethyl-4-hydroxy Tamoxifen (approx. 1:1 E/Z Mixture) 110025-28-0 C25H27NO2
Rebeprazole sulfone N-oxide Rebeprazole sulfone N-oxide 924663-37-6 C18H21N3O5S
Benzeneethanamine, 4-nitro-N-(2-phenylethyl)-, hydrochloride (1:1) Benzeneethanamine, 4-nitro-N-(2-phenylethyl)-, hydrochloride (1:1) 1581285-28-0 C16H19ClN2O2
D-Glucopyranose, oligomeric, C8-10-alkyl glycosides D-Glucopyranose, oligomeric, C8-10-alkyl glycosides 161074-97-1
Odaterol Impurity 34 Odaterol Impurity 34
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