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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
Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate 82398-34-3 C12H24N5O5Pt2+
(1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester 171596-44-4 C20H18N2O4
Amlodipine-d4 Amlodipine-d4 1185246-14-3 C20H25ClN2O5
3-(1-Naphthalenyloxy)propiophenone 3-(1-Naphthalenyloxy)propiophenone 41198-42-9 C19H16O2
2-(1,3,2-Dioxaborinan-2-yl)benzamide 2-(1,3,2-Dioxaborinan-2-yl)benzamide 2377611-18-0 C10H12BNO3
Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) 5740-62-5 C24H32O6
(1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate (1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate 229614-51-1 C16H30N4O4
Bis(4-fluorobenzyl)aMine, 97% Bis(4-fluorobenzyl)aMine, 97% 134227-41-1 C14H13F2N
(3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester (3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester 1292296-09-3 C38H52N6O7
L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride 142963-69-7 C14H23ClN6O4
8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 432543-89-0 C19H20Cl2N2
1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 141745-71-3 C25H29N3O2
PF 2825 PF 2825 153012-65-8 C21H28N2O5S
3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 444057-64-1 C24H27ClN4O6S2
Ertapenem Dimer Form D Impurity Ertapenem Dimer Form D Impurity 1199797-41-5 C44H50N6O14S2
S 00218 S 00218 92700-82-8 C15H22N2O4
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
Loratadine IMpurity D Loratadine IMpurity D C22H23ClN2O2
PeMetrexed EP IMpurity A PeMetrexed EP IMpurity A 869791-42-4 C21H23N5O6
Itraconazole EP IMpurity G Itraconazole EP IMpurity G
(1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride (1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride 1402222-66-5 C9H10ClF2N
IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine 216581-01-0 C30H30N2
21-Dehydro-6α-Methyl Prednisolone 21-Dehydro-6α-Methyl Prednisolone 58636-50-3 C22H28O5
α-Hydroxy Flurbiprofen α-Hydroxy Flurbiprofen 61466-95-3 C15H13FO3
5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 1391194-45-8 C20H21NO3S
9-AcridinaMine, 6-chloro-2-ethoxy- 9-AcridinaMine, 6-chloro-2-ethoxy- 855939-48-9 C15H13ClN2O
Caspofungin IMpurity A Caspofungin IMpurity A 1202167-57-4 C51H86N10O15
DesdifluoroMethoxy Hydroxy Pantoprazole DesdifluoroMethoxy Hydroxy Pantoprazole 1261238-06-5 C15H15N3O4S
Levofloxacin Hydroxy Acid Levofloxacin Hydroxy Acid 1036016-10-0 C18H21F2N3O4
N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine 91147-43-2 C11H11N5
Nor Lidocaine Hydrochloride Nor Lidocaine Hydrochloride 7729-94-4 C12H19ClN2O
rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate 136310-66-2 C18H19NO3S2
(11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one (11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one 709615-25-8 C30H37NO4
4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 1187954-57-9 C32H37NO3
(2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride (2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride 1370331-33-1 C8H17NO5
(3S,5R)-Rosuvastatin (3S,5R)-Rosuvastatin 1242184-42-4 C22H28FN3O6S
(S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide (S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide 119714-13-5 C10H16N2O3S
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Avanafil IMpurity 6 Avanafil IMpurity 6
Cefoxitin iMpurity F (S-Methoxy cefoxitin) Cefoxitin iMpurity F (S-Methoxy cefoxitin)
Clopidogrel IMpurity 1 Clopidogrel IMpurity 1 C15H14ClNO2S
LincoMycin iMpurity A LincoMycin iMpurity A
Posaconazole iMpurity 1 Posaconazole iMpurity 1
Riociguat IMpurtiy Riociguat IMpurtiy 2920299-23-4
TelMisartan IMpurity E TelMisartan IMpurity E
IverMectin B1 Mono-sugar Derivative IverMectin B1 Mono-sugar Derivative 71837-27-9 C41H62O11
Desethyl Acetate (E)-CefuroxiMe Axetil Desethyl Acetate (E)-CefuroxiMe Axetil 97232-97-8 C16H16N4O8S
6-AMino-5-azacytidine 6-AMino-5-azacytidine 105331-00-8 C8H13N5O5
N-Methyl-3-phenylpropan-1-aMine hydrochloride
(RelCpd B) N-Methyl-3-phenylpropan-1-aMine hydrochloride (RelCpd B) 30684-07-2 C10H16ClN
1-[2-[(2,6-diMethylphenyl)thio]phenyl]- Piperazine 1-[2-[(2,6-diMethylphenyl)thio]phenyl]- Piperazine 508233-76-9 C18H22N2S
6-(5-Chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5H-pyrrolo[3,4-b]pyrazin-5-one 6-(5-Chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5H-pyrrolo[3,4-b]pyrazin-5-one 43200-81-3 C11H7ClN4O2
RHENIUM RHENIUM 7440-15-5 Re
7-(4-Chlorobutoxy)-1H-quinolin-2-one 7-(4-Chlorobutoxy)-1H-quinolin-2-one 913613-82-8 C13H14ClNO2
-Oxo-a-propylenanthic Acid Ethyl Ester -Oxo-a-propylenanthic Acid Ethyl Ester 96610-56-9 C12H22O3
5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine 5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine 910129-15-6 C15H22FN3O6
methyl 2,4-bis{2-nitrophenyl}-6-methyl-1,2,3,4-tetrahydro-5-pyrimidinecarboxylate methyl 2,4-bis{2-nitrophenyl}-6-methyl-1,2,3,4-tetrahydro-5-pyrimidinecarboxylate 108139-78-2 C19H18N4O6
Dehydrodeoxy Donepezil (Donepezil Impurity) Dehydrodeoxy Donepezil (Donepezil Impurity) 120013-45-8 C24H29NO2
Zolmitriptan Zolmitriptan 139264-24-7 C16H21N3O2
2,3-Dimethylstyrene 2,3-Dimethylstyrene 40243-75-2 C10H12
1,1'-Biphenyl-2-ylcarbamic acid 1,1'-Biphenyl-2-ylcarbamic acid 50443-60-2 C13H11NO2
2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 62369-72-6 C36H58O10
10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 146-21-4 C17H20N2OS
(6E,10E)-7,11,15-Trimethyl-3-methylene-1,6,10,14-hexadecatetrene (6E,10E)-7,11,15-Trimethyl-3-methylene-1,6,10,14-hexadecatetrene 70901-63-2 C20H32
4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 68128-53-0 C19H33NO13
4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 68128-53-0 C19H33NO13
CLARITHROMYCIN OXIME CLARITHROMYCIN OXIME 127253-06-9 C38H70N2O13
PYRIDINE,3,5-BIS(BROMOMETHYL)- PYRIDINE,3,5-BIS(BROMOMETHYL)- 35991-75-4 C7H7Br2N
alpha-Hydroxy-alpha-phenylbenzeneacetic acid (3-endo)-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride alpha-Hydroxy-alpha-phenylbenzeneacetic acid (3-endo)-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride 63516-30-3 C21H24ClNO3
N-(4-(METHYLAMINO)BENZOYL)-L-GLUTAMIC ACID N-(4-(METHYLAMINO)BENZOYL)-L-GLUTAMIC ACID 52980-68-4 C13H16N2O5
(2R)-N-(2,6-DIMETHYLPHENYL)-2-PIPERIDINECARBOXAMIDE (2R)-N-(2,6-DIMETHYLPHENYL)-2-PIPERIDINECARBOXAMIDE 27262-43-7 C14H20N2O
ICARISIDE B5 ICARISIDE B5 114226-08-3 C19H32O8
2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B) 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B) 1159977-03-3 C10H9Cl2N3O2
2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B) 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B) 1159977-03-3 C10H9Cl2N3O2
Atorvastatin Lactam Impurity Atorvastatin Lactam Impurity 906552-18-9 C33H35FN2O6
1,3-Bis(9H-carbazol-4-yloxy)-2-propanol (Carvedilol Impurity) 1,3-Bis(9H-carbazol-4-yloxy)-2-propanol (Carvedilol Impurity) 1276477-91-8 C27H22N2O3
Atorvastatin Lactone Diepoxide Atorvastatin Lactone Diepoxide 1046118-40-4 C33H33FN2O6
2-Carboxybenzoyl Amlodipine 2-Carboxybenzoyl Amlodipine 318465-73-5 C28H29ClN2O8
rac-trans-4-Desfluoro-4-methoxy Paroxetine Hydrochloride rac-trans-4-Desfluoro-4-methoxy Paroxetine Hydrochloride 127017-74-7 C20H24ClNO4
Des(isopropoxyethyl) Bisoprolol Des(isopropoxyethyl) Bisoprolol 62572-93-4 C13H21NO3
Desmethoxy Fluvoxamine Desmethoxy Fluvoxamine 1217216-82-4 C14H19F3N2O
4'-Deoxy Vincristine 4'-Deoxy Vincristine 68135-16-0 C46H56N4O9
Demethyl Chlorpromazine Hydrochloride Demethyl Chlorpromazine Hydrochloride 3953-65-9 C16H18Cl2N2S
6-Hydroxy-6-defluoro Ciprofloxacin 6-Hydroxy-6-defluoro Ciprofloxacin 226903-07-7 C17H19N3O4
N-(2-Succinyl) Fluvoxamine N-(2-Succinyl) Fluvoxamine 259526-43-7 C19H25F3N2O6
Methylene-Bis Paroxetine Dihydrochloride Methylene-Bis Paroxetine Dihydrochloride 606968-05-2 C39H40F2N2O6
1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 221615-72-1 C15H15NOS
Edaravone Edaravone 68195-63-1 C30H26N6O3
1-NaphthaleneMethanaMine, α-Methyl-N-[[3-(trifluoroMethyl)phenyl]Methyl]-, (αR)- 1-NaphthaleneMethanaMine, α-Methyl-N-[[3-(trifluoroMethyl)phenyl]Methyl]-, (αR)- 1229512-52-0 C20H18F3N
Benzoic acid, 2-[[[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]aMino]carbonyl]- Benzoic acid, 2-[[[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]aMino]carbonyl]- 1365267-37-3 C22H21N3O7
NSC 609249 NSC 609249 51012-67-0 C12H20ClNO2
Doxorubicin Impurity 6 Doxorubicin Impurity 6 69429-21-6 C26H27NO11
Etoricoxib Impurity 11 Etoricoxib Impurity 11 202409-31-2 C17H13ClN2O2S
Levofloxacin Tetrafluoro Impurity 1 Levofloxacin Tetrafluoro Impurity 1 110548-02-2 C15H15F4NO4
Penicillin F Potassium Salt Penicillin F Potassium Salt 97299-13-3 C14H21KN2O4S
Olaparib Impurity 31 Olaparib Impurity 31 458535-34-7 C12H18N2O2
Macitentan impurity A Macitentan impurity A 441798-25-0 C17H16Br2N6O4S
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