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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
Vonoprazan Impurity 4 Vonoprazan Impurity 4
Vortioxetine Impurity 25 Vortioxetine Impurity 25 1639263-80-1 C18H22N2O2S
Cinacalcet Impurity B Cinacalcet Impurity B 66469-40-7 C19H19N
Dapagliflozin Impurity D Dapagliflozin Impurity D 2133407-75-5 C21H25ClO6
Escitalopram Impurity Escitalopram Impurity 91283-87-3 C18H14FNO3
Furosemide Imp.(EP) Furosemide Imp.(EP)
Nifuratel Impurity Nifuratel Impurity 167103-07-3 C6H5N3O4
Vinpocetine Impurity Vinpocetine Impurity 102341-40-2 C19H23N3O
2-amino-9-((1R,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 2-amino-9-((1R,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 1367369-81-0 C12H15N5O3
N-(3,4-dichlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine N-(3,4-dichlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine 2089650-13-3 C22H24Cl2N4O3
Moxifloxacin Impurity 8 Moxifloxacin Impurity 8
(3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid (3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid C33H35FN2O5
Olaparib Imp.2 Olaparib Imp.2
Ciprofloxacin impurity I Ciprofloxacin impurity I C17H18FN3O3
5-(4'-((2-butyl-4-chloro-5-(isopropoxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole 5-(4'-((2-butyl-4-chloro-5-(isopropoxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole 1332713-64-0 C25H29ClN6O
Afatinib Impurity L (Afatinib N-Oxide) Afatinib Impurity L (Afatinib N-Oxide)
Afatinib Impurity L (Afatinib N-Oxide) Afatinib Impurity L (Afatinib N-Oxide)
Mirabegron Deshydroxy Mirabegron Deshydroxy 1581284-82-3 C21H24N4OS
4-Thiazoleacetyl chloride, 2-amino-, monohydrochloride
4-Thiazoleacetyl chloride, 2-amino-, monohydrochloride 66313-72-2 C5H6Cl2N2OS
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
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
Oseltamivir Impurity Oseltamivir Impurity 221386-94-3 C11H17N3O5
Cefradine Impurity J Cefradine Impurity J
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
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
Rocuronium Bromide Impurity 19 、21、22 Rocuronium Bromide Impurity 19 、21、22
Flucloxacillin impurity D Flucloxacillin impurity D
Ritonavir EP Impurity STU Ritonavir EP Impurity STU
Letermovir Impurity 1 Letermovir Impurity 1
Roxadustat Impurity 16 Roxadustat Impurity 16
Perospirone Impurity 19 Perospirone Impurity 19
Dolutegravir Impurity 14(Sodium Salt) Dolutegravir Impurity 14(Sodium Salt)
Fondaparinux sodium impurity 5 Fondaparinux sodium impurity 5
Fondaparinux sodium impurity 20 Fondaparinux sodium impurity 20
Piperacillin  Impurity R Piperacillin Impurity R
Lasmiditan Impurity 6 Lasmiditan Impurity 6
1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride 1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride
Lasmiditan Impurity 8 Lasmiditan Impurity 8
1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 2760465-02-7 C17H22N4O2S
Ethacridine Impurity 10 Ethacridine Impurity 10 20304-71-6 C21H16N2O4
(S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide (S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide 135729-78-1 C18H24N2O
2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
Olodaterol Impurity 31 Olodaterol Impurity 31
(S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide 192726-05-9 C27H38N4O3
2-Hydrazinoadenosine 2-Hydrazinoadenosine 15763-11-8 C10H15N7O4
N-Desmethyl Clarithromycin N-Desmethyl Clarithromycin 101666-68-6 C37H67NO13
(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
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