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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
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
Axitinib Impurity 14 Axitinib Impurity 14
Nicorandil Impurity 7 Nicorandil Impurity 7
Ritonavir EP Impurity T Ritonavir EP Impurity T 869368-48-9 C46H66N8O5S2
4-Methoxy-a-methyl-L-phenylalanine 4-Methoxy-a-methyl-L-phenylalanine 65555-88-6 C11H15NO3
Cyanocobalamin Cyanocobalamin 38218-55-2 C63H87CoN13O15P
Empagliflozin Impurity 44 Empagliflozin Impurity 44
1,4,8,11- tetra(trifluoroacetyl)-1,4,8,11-tetraazacyclotetradecane 1,4,8,11- tetra(trifluoroacetyl)-1,4,8,11-tetraazacyclotetradecane 201610-16-4 C18H20F12N4O4
5-bromo-4-(4-chlorothiophen-2-yl)thiazol-2-amine 5-bromo-4-(4-chlorothiophen-2-yl)thiazol-2-amine 2161380-87-4 C7H4BrClN2S2
Zopiclone Impurity 11 Zopiclone Impurity 11
(3R,5S)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonam ido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate calcium(II) (3R,5S)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonam ido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate calcium(II) 854898-49-0 C44H54CaF2N6O12S2
Doxorubicin EP Impurity C HBr Doxorubicin EP Impurity C HBr 60873-68-9 C27H29Br2NO10
Ceftazidime Impurity K Ceftazidime Impurity K
Furosemide Impurity 3 Furosemide Impurity 3 C12H11ClN2O5S
Nicorandil Impurity 13 Nicorandil Impurity 13 19416-51-4 C9H11NO3
Rosuvastatin Impurity 51 Rosuvastatin Impurity 51
Silodosin Impurity 3 Silodosin Impurity 3 1402161-34-5 C29H31N3O2
Tenofovir Impurity 61 Tenofovir Impurity 61
Ticagrelor Impurity 70 Ticagrelor Impurity 70 1824025-11-7
Topiroxostat Impurity 21 Topiroxostat Impurity 21 2044704-74-5 C13H7N5O
Mirabegron Impurity 17 Mirabegron Impurity 17 1684452-84-3 C31H32N8O4S3
Afatinib Impurity 24 Afatinib Impurity 24
Amifostine Impurity 8 Amifostine Impurity 8 66487-25-0 C5H10N2O
Bendamustine Impurity 33 Bendamustine Impurity 33
Bendamustine Impurity 38 Bendamustine Impurity 38
Ciprofloxacin Impurity 4 Ciprofloxacin Impurity 4 C17H18FN3O3
Dapagliflozin Impurity 29 Dapagliflozin Impurity 29
Erlotinib Impurity 52 Erlotinib Impurity 52
Etoposide Impurity 3 Etoposide Impurity 3
Nintedanib Impurity 29 Nintedanib Impurity 29
Olaparib Impurity 23 Olaparib Impurity 23
Oseltamivir Impurity 19 Oseltamivir Impurity 19
(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
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
Rocuronium bromide Impurity 30 Rocuronium bromide Impurity 30 56240-11-0 C19H26O
Rocuronium Bromide Impurity 38 Rocuronium Bromide Impurity 38
S-Silodosin S-Silodosin 2182279-45-2 C25H32F3N3O4
Terazosin EP Impurity D Terazosin EP Impurity D 102714-74-9 C15H19N5O3
Apremilast Impurity FA Apremilast Impurity FA 2077897-94-8 C21H22N2O7S
Atracurium Impurity S Atracurium Impurity S
Mirabegron Impurity MADT Mirabegron Impurity MADT
Palbociclib Impurity 30 Palbociclib Impurity 30
Parecoxib Impurity Q Parecoxib Impurity Q 1373038-58-4 C16H14N2O3S
Ropivacaine Impurity 30 Ropivacaine Impurity 30
Ropivacaine Impurity 39 Ropivacaine Impurity 39
Sugammadex sodium Org46643 Impurity Sugammadex sodium Org46643 Impurity
Afatinib impurity 27 Afatinib impurity 27
Butyphthalide impurity 41 Butyphthalide impurity 41 1379166-79-6 C9H10O3
Butyphthalide impurity 47 Butyphthalide impurity 47
Dapoxetine impurity 19 Dapoxetine impurity 19
Empagliflozin Impurity KHC Empagliflozin Impurity KHC
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
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)
(1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride (1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride 101900-44-1 C13H20BrClN2O
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