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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
nicergoline impurity Q nicergoline impurity Q
Loratadine Impurity 19 Loratadine Impurity 19 79779-58-1 C22H24N2O2
(Z)-2-chloro-3-hydroxyacrylaldehyde (Z)-2-chloro-3-hydroxyacrylaldehyde 50704-42-2 C3H3ClO2
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4''-fluoro-[1,1''-biphenyl]-4-yl)-1-methylpiperidine hydrochloride (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4''-fluoro-[1,1''-biphenyl]-4-yl)-1-methylpiperidine hydrochloride
Ticagrelor Related Compound 39 Ticagrelor Related Compound 39
Erlotinib Impurity 32 Erlotinib Impurity 32
Pramipexole Impurity 36 Pramipexole Impurity 36
Teneligliptin Impurity 3 Teneligliptin Impurity 3
Erlotinib Hydrochloride iMpurity 52 Erlotinib Hydrochloride iMpurity 52
Ornidazole Impurity J Ornidazole Impurity J 742020-47-9 C7H12N4O3
Daidzein-4′-glucoside Daidzein-4′-glucoside 58970-69-7 C21H20O9
Aprepitant iMpurity 45 Aprepitant iMpurity 45
Afatinib Impurity 75 Afatinib Impurity 75 2348580-72-1 C7H14N2O
Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl) Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl) 159325-45-8 C23H35NO2
(2b,3a,16b,17b)-2,16-Bispiperidino-3,17-diacetoxy-5-androstane (2b,3a,16b,17b)-2,16-Bispiperidino-3,17-diacetoxy-5-androstane 13529-31-2 C33H54N2O4
Palbociclib Impurity 59 Palbociclib Impurity 59 1430196-98-7 C14H20N4O4
Landiolol impurity Z Landiolol impurity Z
Vitamin K1 Impurity 1 Vitamin K1 Impurity 1 19274-66-9 C31H46O2
Omeprazole EP Impurity G Omeprazole EP Impurity G 125656-83-9 C16H13N3O2S
Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- 4180-30-7 C11H22N4O
Cefdinan impurity S Cefdinan impurity S
(4S)-2-(((R)-2-Amino-2-phenylacetamido)(carboxy)-methyl)-5,5-dimethylthiazolidine-4-carboxylic (4S)-2-(((R)-2-Amino-2-phenylacetamido)(carboxy)-methyl)-5,5-dimethylthiazolidine-4-carboxylic 1642629-93-3 C16H21N3O5S
3,3'-(ethane-1,2-diyl)bis(1-(2-chloroethyl)-1H-benzo[d]imidazol-2(3H)-one) 3,3'-(ethane-1,2-diyl)bis(1-(2-chloroethyl)-1H-benzo[d]imidazol-2(3H)-one) 191977-79-4 C20H20Cl2N4O2
octakis(6-chloro-6-deoxy)-γ-cyclodextrin octakis(6-chloro-6-deoxy)-γ-cyclodextrin 173094-60-5 C48H72Cl8O32
N-[4-(difluoromethoxy)-2-nitrophenyl]acetamide N-[4-(difluoromethoxy)-2-nitrophenyl]acetamide 97963-75-2 C9H8F2N2O4
Ropivacaine-ET Ropivacaine-ET 2180-94-1 C16H24N2O
Pitavastatin Dihydrobenzophenanthridine Pitavastatin Dihydrobenzophenanthridine 1187966-91-1 C25H24FNO4
BDJS-SH 3 BDJS-SH 3 1817657-89-8 C12H18N2O2
Ampicillin EP Impurity N Ampicillin EP Impurity N
Apixaban Impurity 20 Apixaban Impurity 20
Aprepitant Impurity 19 Aprepitant Impurity 19 1333995-14-4
Blonanserin impurity E Blonanserin impurity E
Clindamycin Impurity 17 Clindamycin Impurity 17
Edaravone Impurity 12 Edaravone Impurity 12 2061958-41-4 C12H16N2O2
Empagliflozin Impurity 19 Empagliflozin Impurity 19
Erythromycin impurity D Erythromycin impurity D
FeBuxostat Impurity 40 FeBuxostat Impurity 40
Formoterol Impurity 13 Formoterol Impurity 13 150513-24-9 C18H24N2O3
Fosaprepitant Impurity 4 Fosaprepitant Impurity 4 1523569-85-8 C37H34F7N4O6P
Fudosteine Impurity 2 Fudosteine Impurity 2 1480319-53-6 C6H13NO5S
Ilaprazole Impurity 1 Ilaprazole Impurity 1
Ilaprazole Impurity 2 Ilaprazole Impurity 2
Isavuconazole Impurity 10 Isavuconazole Impurity 10
Teneligliptin Impurity 13 Teneligliptin Impurity 13
Ceftazidime EP Impurity D Ceftazidime EP Impurity D 73547-69-0 C45H44N6O7S2
Nicergoline EP Impurity G Nicergoline EP Impurity G 57935-65-6 C23H24BrN3O2
Benzenesulfonamide, 4-[5-(4-methylphenyl)-2-oxido-3-(trifluoromethyl)-1H-pyrazol-1-yl]- Benzenesulfonamide, 4-[5-(4-methylphenyl)-2-oxido-3-(trifluoromethyl)-1H-pyrazol-1-yl]- 2356153-95-0 C17H14F3N3O3S
2-Pyrrolidinecarbonitrile, 1-(2-aminoacetyl)-, hydrochloride (1:1), (2S)- 2-Pyrrolidinecarbonitrile, 1-(2-aminoacetyl)-, hydrochloride (1:1), (2S)- 913980-23-1 C7H12ClN3O
Lamivudine Impurity 7 Lamivudine Impurity 7 147126-63-4 C14H24O4S
EsCitalopram EP Impurity I EsCitalopram EP Impurity I 1370643-22-3 C20H21FN2O
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine 127017-42-9 C21H25NO4
Methylprednisolone Impurity 21 Methylprednisolone Impurity 21 150899-33-5 C22H28O4
Epinephrine Impurity 7 Epinephrine Impurity 7 62322-82-1 C9H11NO3
(trans)-4-((2-amino-4,6-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-4,6-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 53944-31-3 C14H11NO2
2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 612503-08-9 C12H11N3S
Paroxetine IMpurity Paroxetine IMpurity
7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C14H16FN3O3
(S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate (S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate 61616-97-5 C17H21NO3
AlviMopan iMpurity AlviMopan iMpurity
Caspofungin iMpurity Caspofungin iMpurity
Saxagliptin iMpurity Saxagliptin iMpurity 2173146-35-3 C18H24ClN3O2
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
(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 C8H11Cl2NO
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 C27H32N2O6
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
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 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
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
4,5-DICHLOROTHIOPHENE-2-CARBOXYLIC ACID 4,5-DICHLOROTHIOPHENE-2-CARBOXYLIC ACID 31166-29-7 C5H2Cl2O2S
N,O-Dibenzylated formoterol N,O-Dibenzylated formoterol 43229-70-5 C33H36N2O4
1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 4097-90-9 C10H28N6
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