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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
Febuxostat Impurity 70 Febuxostat Impurity 70 2418591-43-0 C16H16N2O3S
Febuxostat Impurity 92 Febuxostat Impurity 92
Fluconazole Impurity N Fluconazole Impurity N C13H12F2N6O
Ibrutinib Impurity 25 Ibrutinib Impurity 25 2052279-48-6 C28H28N6O4
Ipratropium Bromide Impurity 2 Ipratropium Bromide Impurity 2 C20H29Br2NO3
Lenvatinib Impurity 21 Lenvatinib Impurity 21
Moxifloxacin Impurity 45 Moxifloxacin Impurity 45
Olaparib Impurity O Olaparib Impurity O
Olsalazine Impurity D Olsalazine Impurity D
Parecoxib sodium Impurity 34 Parecoxib sodium Impurity 34
Tofacitinib Impurity 19 Tofacitinib Impurity 19 2056104-91-5 C27H31N5O2S
Topiroxostat Impurity 29 Topiroxostat Impurity 29
Vildagliptin Impurity ZA6 Vildagliptin Impurity ZA6 2246354-69-6 C17H23N3O2
Nintedanib Impurity O Nintedanib Impurity O
Palonosetron Impurity TM1-SS Palonosetron Impurity TM1-SS 1260610-96-5 C15H23ClN2
Amoxicillin EP impurity P Amoxicillin EP impurity P C16H19N3O5S
Eltrombopag Impurity 3 Eltrombopag Impurity 3
Saxagliptin Impurity 5 (Epoxy saxaglliptin) Saxagliptin Impurity 5 (Epoxy saxaglliptin)
(2S,4S)-5-(Biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2-methylpentanoic acid ethyl ester,calcium salt(2:1) (2S,4S)-5-(Biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2-methylpentanoic acid ethyl ester,calcium salt(2:1)
Diltiazem impurity Diltiazem impurity 115992-91-1 C17H18N2O3S
Raloxifene EP IMpurity Raloxifene EP IMpurity 1700655-64-6 C13H15ClN2O2S
Parecoxib Impurity M Parecoxib Impurity M
(-)-Lyoniresinol 9'-O-glucoside (-)-Lyoniresinol 9'-O-glucoside 143236-02-6 C28H38O13
Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- 1648791-23-4 C29H43N5
1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1822601-94-4 C12H15N
Sofosbuvir metabolites Sofosbuvir metabolites 1859162-80-3 C16H18FN2O8P
1,3,5,7-tetrahydroxyadamantane 1,3,5,7-tetrahydroxyadamantane 16104-28-2 C10H16O4
Cabozantinib Impurity E Cabozantinib Impurity E
Loxoprofen Impurity I Loxoprofen Impurity I
Sofosbuvir Impurity22 Sofosbuvir Impurity22
Donepezil Impurity-OH Donepezil Impurity-OH 148517-82-2 C11H12O4
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-(hydroxyamino)pyrimidin-2-one 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-(hydroxyamino)pyrimidin-2-one 13491-41-3 C9H13N3O6
1-(2-amino-4,5-dimethoxyphenyl)ethan-1-one 1-(2-amino-4,5-dimethoxyphenyl)ethan-1-one 1071574-51-0 C10H13NO3
(+)-epipinoresinol-4-O-β-D-glucoside (+)-epipinoresinol-4-O-β-D-glucoside 74983-66-7 C26H32O11
2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylthio-1H-benzimidazole 2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylthio-1H-benzimidazole 103577-40-8 C16H14F3N3OS
Ethyl (3E)-3-(2-phenylhydrazin-1-ylidene)butanoate Ethyl (3E)-3-(2-phenylhydrazin-1-ylidene)butanoate 6078-46-2 C12H16N2O2
1-(5,6-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(5,6-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1824506-44-6 C12H15N
(S)-4-(4-((3-amino-2-hydroxypropyl)amino)phenyl)morpholin-3-one hydrochloride (S)-4-(4-((3-amino-2-hydroxypropyl)amino)phenyl)morpholin-3-one hydrochloride 1403383-55-0 C13H20ClN3O3
Terbutaline  Impurity Terbutaline Impurity 882066-15-1 C33H35NO3.H2O4S
Bis(4-fluorobenzyl)aMine Bis(4-fluorobenzyl)aMine 646051-52-7 C14H13F2N
2-(2-butyl-4-methyl-1-((2'-(1-methyl-
1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-
yl)methyl)-6-oxo-1,6-
dihydropyrimidin-5-yl)-N,Ndimethylethanethioamide
2-(2-butyl-4-methyl-1-((2'-(2-methyl-
2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-
yl)methyl)-6-oxo-1,6-
dihydropyri 2-(2-butyl-4-methyl-1-((2'-(1-methyl- 1H-tetrazol-5-yl)-[1,1'-biphenyl]-4- yl)methyl)-6-oxo-1,6- dihydropyrimidin-5-yl)-N,Ndimethylethanethioamide 2-(2-butyl-4-methyl-1-((2'-(2-methyl- 2H-tetrazol-5-yl)-[1,1'-biphenyl]-4- yl)methyl)-6-oxo-1,6- dihydropyri
ethyl 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylate C22H26FN3O4
Matairesinol monoglucoside Matairesinol monoglucoside 34446-06-5 C26H32O11
Apremilast Apremilast 1384967-20-7 C20H20N2O7S
Pramipexole Impurity 30 Pramipexole Impurity 30 1802051-36-0 C13H24ClN3S
NZWJKTHFNLHUJO-NWZSJJIMSA-N NZWJKTHFNLHUJO-NWZSJJIMSA-N 1422954-12-8 C22H26FN3O5S
LAT-NET LAT-NET 607351-44-0 C25H39NO4
N,N-(ethane-1,2-diyl)bis(4-methyl-N-(3-((4-methylphenyl)sulfonamido)propyl)benzenesulfonamide) N,N-(ethane-1,2-diyl)bis(4-methyl-N-(3-((4-methylphenyl)sulfonamido)propyl)benzenesulfonamide) 74676-47-4 C36H46N4O8S4
L-GLUCONO-1,5-LACTONE L-GLUCONO-1,5-LACTONE 52153-09-0 C6H10O6
C-Desmethyl Atenolol C-Desmethyl Atenolol 1797116-92-7 C13H20N2O3
Arthromerin B Arthromerin B 31049-08-8 C21H22O11
Losartan Impurity 7 Losartan Impurity 7 358685-13-9 C33H24Br2N4
Fenofibric Acid 1-Carboxyl-1-methylethyl Ester Fenofibric Acid 1-Carboxyl-1-methylethyl Ester 1797121-54-0 C21H21ClO6
(1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride (1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride 101900-44-1 C13H20BrClN2O
Linagliptin Impurity O Linagliptin Impurity O
Linagliptin Impurity T Linagliptin Impurity T
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide C18H22FN5O3
Apremilast Impurity 2 Apremilast Impurity 2
Etoricoxib Impurity 16 Etoricoxib Impurity 16
Ibrutinib Impurity 2 Ibrutinib Impurity 2
Mirabegron Impurity 14 Mirabegron Impurity 14
Vonoprazan Impurity 1 Vonoprazan Impurity 1 881732-90-7 C17H17N3O2S
Atenolol EP Impurity Atenolol EP Impurity C14H22N2O3
Cinacalcet Impurity 20 Cinacalcet Impurity 20
Dapagliflozin Impurity 11 Dapagliflozin Impurity 11
Dasatinib Impurity C Dasatinib Impurity C
Etoricoxib impurity Q Etoricoxib impurity Q 292067-97-1 C18H15ClN2S
Flucloxacillin Impurity Flucloxacillin Impurity
Fluorometholone Impurity Fluorometholone Impurity 2796-99-8 C23H31FO7S
Verapamil Impurity Verapamil Impurity 1551304-28-9 C12H19NO2
Clopidogrel impurity reference substance Clopidogrel impurity reference substance C15H14ClNO2S
Vildagliptin Impurity Vildagliptin Impurity
Aloeemodin-ω-O-β-D-glucopyranoside Aloeemodin-ω-O-β-D-glucopyranoside 29010-56-8 C21H20O10
ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate 2029205-62-5 C26H25ClN4O4
1-Butanaminium, N,N,N-tributyl-, (1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl sulfate 1-Butanaminium, N,N,N-tributyl-, (1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl sulfate 1192651-80-1 C23H46N4O6S
Dihydroxyoxaliplatin(Oxaliplatin Impurity Ⅲ) Dihydroxyoxaliplatin(Oxaliplatin Impurity Ⅲ)
cefditoren E-isomer(C=C) cefditoren E-isomer(C=C)
Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ
2-Ethoxybenzimidohydrazide 2-Ethoxybenzimidohydrazide 889943-46-8 C9H13N3O
(41S,12S,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid (41S,12S,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid 59413-21-7 C20H25N2NaO3
BDJS-SH 1 BDJS-SH 1 36588-45-1 C12H18N2O2
Acyclovir Impurity O Acyclovir Impurity O
Alogliptin Impurity 19 Alogliptin Impurity 19
Aprepitant Impurity 17 Aprepitant Impurity 17 1333998-27-8 C20H19ClF7NO2
Blonanserin impurity A Blonanserin impurity A
Captopril impurity 2 Captopril impurity 2
Ciprofloxacin Impurity D HCl Ciprofloxacin Impurity D HCl 526204-10-4 C17H18FN3O3
Clindamycin Impurity 6 Clindamycin Impurity 6
Dabigatran Impurity 5 Dabigatran Impurity 5
DecitaBine Impurity 10 DecitaBine Impurity 10
Empagliflozin Impurity 17 Empagliflozin Impurity 17 2452301-27-6 C23H28O7
Erlotinib Impurity 31 Erlotinib Impurity 31
Everolimus impurity C Everolimus impurity C
Ezetimibe Impurity 28 Ezetimibe Impurity 28
FeBuxostat Impurity 30 FeBuxostat Impurity 30
Fluconazole Impurity 5 Fluconazole Impurity 5 94952-36-0 C13H12F2N6O
Fosaprepitant Impurity 2 Fosaprepitant Impurity 2
Imidafenacin Impurity 4 Imidafenacin Impurity 4 503598-78-5 C16H18N2O
Intedanib Impurity H Intedanib Impurity H
Isavuconazole Impurity 16 Isavuconazole Impurity 16
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