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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
Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester 1187954-56-8 C33H41NO4
D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- 50896-99-6 C22H43N5O13
3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 331258-36-7 C28H25ClN2O7
Isomer 1 of Tazobactam Impurity 3 Isomer 1 of Tazobactam Impurity 3
Ceftiofur USP Impurity I Ceftiofur USP Impurity I
Aztreonam Open-Ring Impurity Aztreonam Open-Ring Impurity 102579-58-8 C13H19N5O9S2
Cephalexin Degradation Impurity A Cephalexin Degradation Impurity A
Azlocillin Impurity 8 Azlocillin Impurity 8
Pregabalin-8687(mixture of 4 isomers) Pregabalin-8687(mixture of 4 isomers)
7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one 1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one
(E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine (E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Dolutegravir Impurity C Dolutegravir Impurity C 1802141-49-6 C22H23F2N3O5
Adefovir Dipivoxil Impurity 24 Adefovir Dipivoxil Impurity 24 116384-58-8 C14H23O7PS
Dapoxetine Impurity 68 Dapoxetine Impurity 68 119357-48-1 C19H18O
Tobramycin Impurity Tobramycin Impurity 74501-86-3 C18H35N5O8
Peramivir Impurity 24 Peramivir Impurity 24
2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 79999-39-6 C16H18ClN5O7
Chlorocriptine Chlorocriptine 68944-88-7 C32H40ClN5O5
PD 312237 PD 312237 501666-23-5 C20H35NO11
(1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester (1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester 1234858-94-6 C13H20O4
2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 857170-72-0 C14H23ClN2O
4-Hydroxy Darunavir 4-Hydroxy Darunavir 313682-97-2 C27H37N3O8S
Deschloroaripiprazole Deschloroaripiprazole 203395-81-7 C23H28ClN3O2
O-[(Guanin-9-yl)Methyl] Acyclovir O-[(Guanin-9-yl)Methyl] Acyclovir 166762-90-9 C14H16N10O4
3-(4-Carboethoxy)phenyl propanal 3-(4-Carboethoxy)phenyl propanal 151864-81-2 C12H14O3
(2,6-Xylyloxy)acetyl Lopinavir (2,6-Xylyloxy)acetyl Lopinavir 943250-65-5 C47H58N4O7
(S)-IsotiMolol (TiMolol IMpurity B) (S)-IsotiMolol (TiMolol IMpurity B) 158636-96-5 C13H24N4O3S
Afatinib IMpurity A Afatinib IMpurity A
Afatinib IMpurity G Afatinib IMpurity G
Articaine IMpurity F (Articaine Acid PropionaMide HCl) Articaine IMpurity F (Articaine Acid PropionaMide HCl)
Avanafil iMpurity 4 Avanafil iMpurity 4 874482-97-0 C8H10ClNO.ClH
Clopidogrel IMpurity 4 Clopidogrel IMpurity 4 801319-16-4 C15H14ClNO2S
Dehydro Azelnidipine Dehydro Azelnidipine 918659-10-6 C33H32N4O6
DiazepaM IMpurity F DiazepaM IMpurity F 31269-33-7 C16H13ClN2O
LaMotrigine IMpurity LaMotrigine IMpurity
Posaconazole DiastereoisoMer interMediate 5 Posaconazole DiastereoisoMer interMediate 5 149809-42-7 C21H21F2N3O4S
Prasugrel alpha-Hydroxy IMpurity Prasugrel alpha-Hydroxy IMpurity 1100905-45-0 C11H11FO2
Solifenacin Related CoMpound 2 Succinate Solifenacin Related CoMpound 2 Succinate 1262506-09-1 C23H26N2O2.C4H6O4
Tetrahydro FuroseMide Tetrahydro FuroseMide 4793-38-8 C12H15ClN2O5S
6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride 6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride 183320-04-9 C21H21Cl2N3O3
alpha-(Dimethylaminomethyl)-alpha-ethylbenzyl alcohol hydrochloride alpha-(Dimethylaminomethyl)-alpha-ethylbenzyl alcohol hydrochloride 104743-23-9 C12H20ClNO
N-[6,9-Dihydro-6-oxo-9-[[2-(1-oxopropoxy)-1-[(1-oxopropoxy)methyl]ethoxy]methyl]-1H-purin-2-yl]propanamide N-[6,9-Dihydro-6-oxo-9-[[2-(1-oxopropoxy)-1-[(1-oxopropoxy)methyl]ethoxy]methyl]-1H-purin-2-yl]propanamide 177216-32-9 C18H25N5O7
5-Bromo-1-(4-fluorophenyl)-1,3-dihydro-N,N-dimethyl-1-isobenzofuranpropanamine ethanedioate (1:1) 5-Bromo-1-(4-fluorophenyl)-1,3-dihydro-N,N-dimethyl-1-isobenzofuranpropanamine ethanedioate (1:1) 64372-43-6 C21H23BrFNO5
(E)-2-Methyl-4-(4-(2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)-10H-benzo[b]thieno[2,3-e][1,4]diazepine (E)-2-Methyl-4-(4-(2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)-10H-benzo[b]thieno[2,3-e][1,4]diazepine 1070876-09-3 C28H26N6S2
(1S,2S,3R,5S)-PinanediolN-BOC-L-phenylalanine-L-leucine boronate (1S,2S,3R,5S)-PinanediolN-BOC-L-phenylalanine-L-leucine boronate 1187479-72-6 C29H45BN2O5
Posaconazole iMpurity 7 Posaconazole iMpurity 7 2180759-84-4 C37H42F2N8O4
Intedanib Impurity Intedanib Impurity 2243396-74-7 C31H32N6O6
Donepezil Impurity 3 Donepezil Impurity 3 1023500-88-0 C24H27NO4
Fesoterodine Related Impurity 4 Fesoterodine Related Impurity 4 214601-12-4 C22H29NO2
Prasugrel Impurity 14 Maleate Prasugrel Impurity 14 Maleate 1373350-60-7 C24H25BrFNO7S
Sofosbuvir Impurity 32 Sofosbuvir Impurity 32 1157884-58-6 C20H17FO6
Torsemide Related Compound 1 Torsemide Related Compound 1 947327-54-0 C13H13N3O2S
Vortioxetine Impurity 3 Vortioxetine Impurity 3 508233-82-7 C17H20N2S
Dehydrocarteolol Hydrochloride Dehydrocarteolol Hydrochloride 62330-84-1 C16H22N2O3
LincoMycin 2-Phosphate LincoMycin 2-Phosphate 27480-30-4 C18H35N2O9PS
Macitentan IMpurity Macitentan IMpurity 556796-88-4 C17H15Br2N5O4S
4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile 4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile 143030-54-0 C16H11BrN4
Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]- Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]- 83881-53-2 C21H26N2O3
AlMotriptan Related CoMpound B AlMotriptan Related CoMpound B 1246860-65-0 C19H25N3O6S
Benazepril Related CoMpound B Benazepril Related CoMpound B
IMatinib  iMpurity IMatinib iMpurity 152459-96-6 C24H21N5O
(2R,3R,4R,5S,6R)-2-(acetoxyMethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate (2R,3R,4R,5S,6R)-2-(acetoxyMethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 2803372-74-7 C32H33FO9S
1,2-BenzenedicarboxaMide, N1,N2-bis[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- 1,2-BenzenedicarboxaMide, N1,N2-bis[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]- 1365267-36-2 C36H36N6O10
2-QuinazolineMethanol, 4-Methyl- 2-QuinazolineMethanol, 4-Methyl- 13535-91-6 C10H10N2O
5-(2,2-diMethyl-4H-benzo[d][1,3]dioxin-6-yl)oxazolidin-2-one 5-(2,2-diMethyl-4H-benzo[d][1,3]dioxin-6-yl)oxazolidin-2-one 452340-96-4 C13H15NO4
5-Chloro-3-sulfino-2-thiophenecarboxylic acid 5-Chloro-3-sulfino-2-thiophenecarboxylic acid 187746-97-0 C5H3ClO4S2
ethyl (S)-10-fluoro-3-methyl-7-oxo- 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate ethyl (S)-10-fluoro-3-methyl-7-oxo- 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate 431058-46-7 C15H14FNO4
methyl (Z)-3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate methyl (Z)-3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate C24H21N3O3
Isavuconazole Impurity 11 Isavuconazole Impurity 11 2732924-99-9 C10H16ClN3O2
Levosimendan Impurity 2 Levosimendan Impurity 2 103416-88-2 C11H12N2O2
Aprepitant EP Impurity B Aprepitant EP Impurity B 2206606-86-0 C29H25F7N4O3
Famotidine EP Impurity A Famotidine EP Impurity A 88061-72-7 C8H15N7O2S3
Meloxicam EP Impurity D Meloxicam EP Impurity D 1331636-17-9 C16H17N3O4S2
Erythromycin Impurity Erythromycin Impurity 40554-78-7 C37H65NO12
Fluconazole EP Impurity I Fluconazole EP Impurity I 150168-54-0 C13H14BrF2N7O
1-benzyl-2-methyl-1H-imidazole-carbaldehyde 1-benzyl-2-methyl-1H-imidazole-carbaldehyde 39269-74-4 C12H12N2O
Sacubitril Impurity Sacubitril Impurity 1015037-46-3 C23H27NO4
Desloratadine Impurity Desloratadine Impurity 50603-12-8 C20H21N
Olaparib Impurity H Olaparib Impurity H
Brexpiprazole Impurity B Brexpiprazole Impurity B
Dapoxetine iMpurity 6 Dapoxetine iMpurity 6
Irbesartan Impurity 4 Irbesartan Impurity 4 C25H28N6O
2-cyclopentylidene-2-phenylacetic acid 2-cyclopentylidene-2-phenylacetic acid C13H14O2
Cabozantinib impurity B Cabozantinib impurity B
Metoprolol IMpurity 3 Metoprolol IMpurity 3 C15H25NO3
Mirabegron Impurity 1 Mirabegron Impurity 1
Desfluoro Pitavastatin Calcium Desfluoro Pitavastatin Calcium 847849-67-6 C25H25NO4
Plerixafor Plerixafor 548488-49-9 C12H23F3N4O
Vonoprazan Impurity 10 Vonoprazan Impurity 10
Vonoprazan Impurity 5 Vonoprazan Impurity 5
Sitagliptin IMpurity 1 Sitagliptin IMpurity 1
Etoricoxib Impurity 7 Etoricoxib Impurity 7
Ezetimibe Impurity D Ezetimibe Impurity D
Alogliptin Imp.13 Alogliptin Imp.13
Erlotinib Imp.18 Erlotinib Imp.18
Ezetimibe (RSS)-Isomer Ezetimibe (RSS)-Isomer 1478664-18-4 C24H21F2NO3
Apremilast Impurity 6 Apremilast Impurity 6
Azilsartan Impurity 16 Azilsartan Impurity 16 1417576-00-1 C28H20N4O8
Regorafenib Impurity 11 Regorafenib Impurity 11 2512204-88-3 C19H18ClFN4O3
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