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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
1,2-bis(bromomethyl)-4,5-dimethoxybenzene 1,2-bis(bromomethyl)-4,5-dimethoxybenzene 26726-81-8 C10H12Br2O2
Alvimopan Impurity 2 Alvimopan Impurity 2
Alvimopan Impurity 4 Alvimopan Impurity 4
Isavuconazole Impurity 13 Isavuconazole Impurity 13
Sofosbuvir Impurity13 Sofosbuvir Impurity13 220503-64-0 C38H31N3O9
21-Acetyl-6β-fluorotriamcinolone Acetonide 21-Acetyl-6β-fluorotriamcinolone Acetonide 67438-37-3 C26H32F2O7
Quetiapine EP Impurity W Quetiapine EP Impurity W 1800608-95-0 C34H32N4O2S2
(2R,3R)-1,1,4,4-tetraphenylbutane-1,2,3,4-tetrol (2R,3R)-1,1,4,4-tetraphenylbutane-1,2,3,4-tetrol 117780-08-2 C28H26O4
(11β,16α)-21-(Acetyloxy)-11,16,17-trihydroxypregna-1,4,14-triene-3,20-dione (11β,16α)-21-(Acetyloxy)-11,16,17-trihydroxypregna-1,4,14-triene-3,20-dione 131918-72-4 C23H28O7
(S)-Alogliptin Benzoate Salt (S)-Alogliptin Benzoate Salt 1638544-64-5 C25H27N5O4
(S)-Alogliptin Benzoate Salt (S)-Alogliptin Benzoate Salt 1638544-64-5 C25H27N5O4
O-Acetyl Silodosin O-Acetyl Silodosin 160970-86-5 C27H34F3N3O5
Azilsartan Impurity Azilsartan Impurity 1675221-59-6 C25H22N2O5
Agomelatine Impurity 1 Agomelatine Impurity 1
Agomelatine Impurity 1 Agomelatine Impurity 1
Olaparib Impurity I Olaparib Impurity I
Brexpiprazole Impurity C Brexpiprazole Impurity C
Dapoxetine Impurity 7 Dapoxetine Impurity 7
3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2374700-40-8 C16H20N6O
7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-2-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- (9CI) 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-2-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- (9CI) 129815-82-3 C18H20FN3O4
Piperazine, 1-[2-[(4-methoxyphenyl)methyl]-4-methylphenyl]- Piperazine, 1-[2-[(4-methoxyphenyl)methyl]-4-methylphenyl]- 769083-63-8 C19H24N2O
1,3-diisopropylurea 1,3-diisopropylurea 4128-37-4 C7H16N2O
Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester 1950587-19-5 C21H14F4N4O3S
LEVETIRACETAM-D6 LEVETIRACETAM-D6 1133229-30-7 C8H14N2O2
Bisoprolol Amlodipine Addition Impurity Bisoprolol Amlodipine Addition Impurity
Bisoprolol Impurity 46 Bisoprolol Impurity 46
Bisoprolol Impurity 37 Bisoprolol Impurity 37
6-Methyl-2,4-pteridinediamine 6-Methyl-2,4-pteridinediamine 708-74-7 C7H8N6
Docetaxel Impurity N Docetaxel Impurity N
Tegoprazan Impurity 14 Tegoprazan Impurity 14
Nirmatrelvir Impurity 7 Nirmatrelvir Impurity 7
4(1H)-Pyridinone, 2-(hydroxymethyl)-3,5-dimethyl- (9CI) 4(1H)-Pyridinone, 2-(hydroxymethyl)-3,5-dimethyl- (9CI) 220757-73-3 C8H11NO2
Irbesartan Impurity 5 Irbesartan Impurity 5 1213252-81-3 C25H28N6O
Cabozantinib impurity C Cabozantinib impurity C
Loratadine Impurity 4 Loratadine Impurity 4 C22H23ClN2O2
Metoprolol IMpurity 4 Metoprolol IMpurity 4 C15H25NO3
Mirabegron Impurity 10 Mirabegron Impurity 10
8-cyclopentyl-6-(1-hydroxyethyl)-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one 8-cyclopentyl-6-(1-hydroxyethyl)-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one 1376615-91-6 C24H31N7O2
Plerixafor Impurity A Plerixafor Impurity A
Ceftazidime Impurity G Ceftazidime Impurity G 138829-73-9 C11H14N4O5S
Vonoprazan Impurity 6 Vonoprazan Impurity 6
Umeclidinium Bromide Impurity 4 Umeclidinium Bromide Impurity 4 869112-31-2 C22H28BrNO2
Deschloro Etoricoxib Deschloro Etoricoxib
Cefazolin impurity B Cefazolin impurity B 1798004-55-3 C16H20N4O4S3.Na
5-chloro-N-(4-((S)-5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)-N-(2-(2-oxo-2-((((S)-2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)amino)ethoxy)ethyl)thiophene-2-carboxamide 5-chloro-N-(4-((S)-5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)-N-(2-(2-oxo-2-((((S)-2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)amino)ethoxy)ethyl)thiophene-2-carboxamide 1632463-24-1 C38H36Cl2N6O10S2
Apremilast Impurity 4 Apremilast Impurity 4 1831833-38-5 C12H16O4S
Rivaroxaban Impurity 16 Rivaroxaban Impurity 16
Topiroxostat Impurity 3 Topiroxostat Impurity 3
Diroxide Impurity 4 Diroxide Impurity 4
(R,E)-4-((3-(3-(diisopropylamino)-1-phenylpropyl)-4-hydroxybenzyl)oxy)-4-oxobut-2-enoic acid (R,E)-4-((3-(3-(diisopropylamino)-1-phenylpropyl)-4-hydroxybenzyl)oxy)-4-oxobut-2-enoic acid C26H33NO5
Flomoxef Impurity 2 Flomoxef Impurity 2 1208982-59-5 C32H30N6O7S
Lincomycin  impurity B Lincomycin impurity B
Valsartan Impurity 1 Valsartan Impurity 1 914465-68-2 C19H21N5O
Axitinib Impurity 2 Axitinib Impurity 2 1428728-83-9 C44H36N8O2S2
3-acetamidophthalic acid 3-acetamidophthalic acid 15371-06-9 C10H9NO5
Dexamethasone EP Impurity E Dexamethasone EP Impurity E 13209-41-1 C22H28O4
Acetic acid, 2-[(5-bromo-2-pyridinyl)amino]-2-oxo-, ethyl ester Acetic acid, 2-[(5-bromo-2-pyridinyl)amino]-2-oxo-, ethyl ester 141354-54-3 C9H9BrN2O3
monocalcium mono((3R,5S,E)-7-(4-(3-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate) monocalcium mono((3R,5S,E)-7-(4-(3-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate)
Peramivir diacetyl impurity 1 Peramivir diacetyl impurity 1
Urapidil Impurity 17 Urapidil Impurity 17
Clindamycin Impurity 86 Clindamycin Impurity 86
Canagliflozin Impurity 77 Canagliflozin Impurity 77
Carbazochrome Sodium Sulfonate Impurity I Carbazochrome Sodium Sulfonate Impurity I
Tadalafil impurities 45 Tadalafil impurities 45
Posaconazole Impurities 10 Complete Set Posaconazole Impurities 10 Complete Set
Cetrorelix Impurity 18 Cetrorelix Impurity 18
Cetrorelix Impurity 13 Cetrorelix Impurity 13
Bortezomib Impurity G Full Set Pre- Bortezomib Impurity G Full Set Pre-
Cetrorelix Impurity 2 (+L-Ser) Cetrorelix Impurity 2 (+L-Ser)
Peramivir Intermediate Impurity 39 Peramivir Intermediate Impurity 39
Peramivir Intermediate Impurity 59 Peramivir Intermediate Impurity 59
Criborole impurity 999 Criborole impurity 999
Atracurium impurity O drops Atracurium impurity O drops
Pemetrexed Disodium Impurity 21-30 Pemetrexed Disodium Impurity 21-30
Bimatoprost Impurity 2 Bimatoprost Impurity 2
Guanosine Guanosine 30747-23-0 C18H21N5O9
Minoxidil Impurity G Minoxidil Impurity G
Brivaracet amoxidation Impurity 2 Brivaracet amoxidation Impurity 2
Sugammadex Impurity U Sugammadex Impurity U
3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)-[1,1'-biphenyl]-2,2'-dicarbonitrile 3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)-[1,1'-biphenyl]-2,2'-dicarbonitrile
Cefmetazole Sodium Impurity B Cefmetazole Sodium Impurity B
(3R,5S,E)-tert-butyl 7-(4-(3-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate (3R,5S,E)-tert-butyl 7-(4-(3-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
1-Piperazinebutanol, 4-(1,2-benzisothiazol-3-yl)- 1-Piperazinebutanol, 4-(1,2-benzisothiazol-3-yl)- 159729-16-5 C15H21N3OS
1,4-Piperazinedibutanol 1,4-Piperazinedibutanol 92036-96-9 C12H26N2O2
1H-Benz[de]isoquinolin-1-one, 2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-6-hydroxy-, (3aS)- 1H-Benz[de]isoquinolin-1-one, 2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-6-hydroxy-, (3aS)- 2446343-19-5 C19H24N2O2
2-yl)oxy)-6,8,11-trihydroxy-8-(((2S,3S,4S,6R)-3-hydroxy-2-methyl-6-(((1S,3S)-3,5,12-trihydroxy-3-(2-hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11- 2-yl)oxy)-6,8,11-trihydroxy-8-(((2S,3S,4S,6R)-3-hydroxy-2-methyl-6-(((1S,3S)-3,5,12-trihydroxy-3-(2-hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11-
Peramivir Impurity 70 Peramivir Impurity 70
PANTOPRAZOLE SULFONE N-OXIDE PANTOPRAZOLE SULFONE N-OXIDE 953787-55-8 C16H15F2N3O6S
(R)-5-(aminomethyl)-2-((R)-carboxy((Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido)methyl)-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R)-5-(aminomethyl)-2-((R)-carboxy((Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido)methyl)-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid
Isavuconazole Impurity 44 Isavuconazole Impurity 44
Cobinic acid-abdeg-pentamide, Co-(cyano-κC)-, dihydrogen phosphate (ester), inner salt, 3'-ester with (5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole-κN3) (9CI) Cobinic acid-abdeg-pentamide, Co-(cyano-κC)-, dihydrogen phosphate (ester), inner salt, 3'-ester with (5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole-κN3) (9CI) 38437-93-3 C63H87CoN13O15P
Avatrombopag Impurity 75 Avatrombopag Impurity 75
Atorvastatin Impurity N(Calcium salt Atorvastatin Impurity N(Calcium salt
medical standard gas medical standard gas
Rosuvastatin Impurity 164 Rosuvastatin Impurity 164
Rosuvastatin Impurity 123 Rosuvastatin Impurity 123
Relugolix Impurity 20 Relugolix Impurity 20
Amoxicillin EP Impurity Q Amoxicillin EP Impurity Q
7-PACE Impurity 2 7-PACE Impurity 2
5-(1-Methyl-4-Piperidyl)5H-Dibenzo 5-(1-Methyl-4-Piperidyl)5H-Dibenzo 3967-32-6 C21H23NO
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