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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
(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
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
CLARITHROMYCIN OXIME CLARITHROMYCIN OXIME 127253-06-9 C38H70N2O13
PYRIDINE,3,5-BIS(BROMOMETHYL)- PYRIDINE,3,5-BIS(BROMOMETHYL)- 35991-75-4 C7H7Br2N
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
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
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
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
Pyrazinecarboxaldehyde, trimethyl- (9CI) Pyrazinecarboxaldehyde, trimethyl- (9CI) 186534-02-1 C8H10N2O
Acetamide, N-[4-[(2R)-3-cyano-2-methyl-1-oxopropyl]phenyl]- Acetamide, N-[4-[(2R)-3-cyano-2-methyl-1-oxopropyl]phenyl]- 2428573-45-7 C13H14N2O2
4-[6-(2-Chloroethyl)-3,6,7,8-tetrahydro-3-methylimidazo[4,5-h][1,4]benzothiazin-2-yl]butanoic acid 4-[6-(2-Chloroethyl)-3,6,7,8-tetrahydro-3-methylimidazo[4,5-h][1,4]benzothiazin-2-yl]butanoic acid 2469039-29-8 C16H21Cl2N3O2S
1-(2-Methoxyphenyl)-4-{3-[4-(2-methoxyphenyl)piperazin-1-yl] propyl}piperazine 1-(2-Methoxyphenyl)-4-{3-[4-(2-methoxyphenyl)piperazin-1-yl] propyl}piperazine
D-erythro-Pent-4-enose, 4,5-dideoxy-2,3-O-(1-methylethylidene)- (9CI) D-erythro-Pent-4-enose, 4,5-dideoxy-2,3-O-(1-methylethylidene)- (9CI) 155934-55-7 C8H12O3
Isavuconazole Impurity 41 Isavuconazole Impurity 41
Carbamic acid, N-benzoyl-N-(2-phenylethyl)-, (2R)-1-azabicyclo[2.2.2]oct-2-yl ester Carbamic acid, N-benzoyl-N-(2-phenylethyl)-, (2R)-1-azabicyclo[2.2.2]oct-2-yl ester 1798817-91-0 C23H26N2O3
4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1,1-bis((5-methylpyridin-3-yl)methyl)piperidin-1-ium 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1,1-bis((5-methylpyridin-3-yl)methyl)piperidin-1-ium
RHENIUM RHENIUM 7440-15-5 Re
Dehydrodeoxy Donepezil (Donepezil Impurity) Dehydrodeoxy Donepezil (Donepezil Impurity) 120013-45-8 C24H29NO2
Zolmitriptan Zolmitriptan 139264-24-7 C16H21N3O2
Aids004544 Aids004544 145397-25-7 C8H10FN3O4
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
Nicorandil N-Oxide Nicorandil N-Oxide 107833-98-7 C8H9N3O5
2-Phenyl-1-[4-(trifluoromethyl)phenyl]ethane 2-(Aminoethyl)oxime (Fluvoxamine Impurity) 2-Phenyl-1-[4-(trifluoromethyl)phenyl]ethane 2-(Aminoethyl)oxime (Fluvoxamine Impurity) 1217241-15-0 C17H17F3N2O
cis-Montelukast cis-Montelukast 774538-96-4 C35H36ClNO3S
(S)-(-)-Tolvaptan (S)-(-)-Tolvaptan 331947-44-5 C26H25ClN2O3
N-tert-Butoxycarbonyl Mirabegron N-tert-Butoxycarbonyl Mirabegron 1329485-55-3 C26H32N4O4S
Phosphine oxide, tris (2-methylphenyl)- Phosphine oxide, tris (2-methylphenyl)- 6163-63-9 C21H21OP
2-(7-Methoxynaphthalen-1-yl)acetamide 2-(7-Methoxynaphthalen-1-yl)acetamide 138113-07-2 C13H13NO2
2-(7-Methoxynaphthalen-1-yl)acetamide 2-(7-Methoxynaphthalen-1-yl)acetamide 138113-07-2 C13H13NO2
2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-,1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium benzenesulfonate 2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-,1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium benzenesulfonate 1075727-06-8 C30H37NO9S
1,2,4-Triazolo[4,3-a]pyrazine, 7-[3-amino-1-oxo-4-(2,4,5-trifluorophenyl)-2-butenyl]-5,6,7,8-tetrahydro- 3-(trifluoromethyl)- 1,2,4-Triazolo[4,3-a]pyrazine, 7-[3-amino-1-oxo-4-(2,4,5-trifluorophenyl)-2-butenyl]-5,6,7,8-tetrahydro- 3-(trifluoromethyl)- 847445-81-2 C16H13F6N5O
4-Difluoromethoxy-2-nitro-aniline 4-Difluoromethoxy-2-nitro-aniline 97963-76-3 C7H6F2N2O3
5,11-dihydro-6H-11-ethyl-4-Methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one 5,11-dihydro-6H-11-ethyl-4-Methyl-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one 133627-17-5 C14H14N4O
2-Pyrazinecarboxamide, N-[(1S)-2-[[(1Z)-3-methyl-1-buten-1-yl]amino]-2-oxo-1-(phenylmethyl)ethyl]- 2-Pyrazinecarboxamide, N-[(1S)-2-[[(1Z)-3-methyl-1-buten-1-yl]amino]-2-oxo-1-(phenylmethyl)ethyl]- 2276538-67-9 C19H22N4O2
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2365474-06-0 C24H27N8O9+
(S)-2-(pentylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid (S)-2-(pentylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid 1332692-49-5 C23H38N2O5S
O-Demethyl elagolix sodium O-Demethyl elagolix sodium 832720-51-1 C31H28F5N3O5
Pitavastatin Impurity 81 Pitavastatin Impurity 81
Carbazochrome Sodium Sulfonate Impurity IV (Carbazochrome Sodium Sulfonate Impurity 4) Carbazochrome Sodium Sulfonate Impurity IV (Carbazochrome Sodium Sulfonate Impurity 4)
Telmisartan EP Impurity B Complete Set Telmisartan EP Impurity B Complete Set
Atracurium Impurity G Complete Set Atracurium Impurity G Complete Set
Cetrorelix Impurity 12 Cetrorelix Impurity 12
Cetrorelix Impurity 5 (6-D-Orn) Cetrorelix Impurity 5 (6-D-Orn)
Tenofovir impurity EE Tenofovir impurity EE
Peramivir Intermediate Impurity 35 Peramivir Intermediate Impurity 35
Peramivir Intermediate Impurity 40 Peramivir Intermediate Impurity 40
Alvatrombopag Impurity 999 Alvatrombopag Impurity 999
Canagliflozin impurities 16 drops Canagliflozin impurities 16 drops
Palonosetron impurity 30XH Palonosetron impurity 30XH
Pazopanib ImpurityABCDEFGHJKL Pazopanib ImpurityABCDEFGHJKL
1-(4-(2-Dimethylamino)-2-ethoxyphenyl butanone 1-(4-(2-Dimethylamino)-2-ethoxyphenyl butanone 68047-07-4 C20H25NO2
Vonoprazan-050-C4H4O4 Vonoprazan-050-C4H4O4 928325-69-3 C21H19ClFN3O6S
Crisaborole Impurity 45 Crisaborole Impurity 45 1785498-37-4 C7H6Br2O
Sugammadex Impurity 26(Org199129-1) Sugammadex Impurity 26(Org199129-1) 2412953-06-9
Gadobutrol Impurity A Gadobutrol Impurity A
2-(4-ethylpiperazin-1-yl)-4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine 2-(4-ethylpiperazin-1-yl)-4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine C24H33N3O
Rosuvastatin Impurity 163 Rosuvastatin Impurity 163
Rosuvastatin Impurity 150 Rosuvastatin Impurity 150
7-PACE Impurity 1 7-PACE Impurity 1
1-(3-Cyanopyridyl-2)-2-Phenyl-4-Methylpyperazine 1-(3-Cyanopyridyl-2)-2-Phenyl-4-Methylpyperazine 61337-88-0 C17H18N4
Ertapenem Impurity E(USP) Ertapenem Impurity E(USP)
Ampicillin Impurity C2 Ampicillin Impurity C2
Tegoprazan Impurity 13 Tegoprazan Impurity 13
Nirmatrelvir Impurity 6 Nirmatrelvir Impurity 6
Bumetanide Impurity 25 Bumetanide Impurity 25
Rocuronium Bromide Impurity 16 、17、18 Rocuronium Bromide Impurity 16 、17、18
Roxadustat Impurity 15 Roxadustat Impurity 15
(1S,3S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H- pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,6,7,8,8a-octahydronaphthalen- 1-yl 2,2-dimethylbutanoate (1S,3S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H- pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,6,7,8,8a-octahydronaphthalen- 1-yl 2,2-dimethylbutanoate 132487-01-5 C25H40O5
3-(hydroxy(2-methyl-1H-imidazol-1-yl)methyl)-9-(hydroxymethyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-(hydroxy(2-methyl-1H-imidazol-1-yl)methyl)-9-(hydroxymethyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one
Perospirone Impurity 18 Perospirone Impurity 18
Perospirone Impurity 3 Perospirone Impurity 3 1002359-81-0 C8H11NO2
Dolutegravir Impurity 13(Sodium Salt) Dolutegravir Impurity 13(Sodium Salt)
Paxlovid Impurity 10 Paxlovid Impurity 10
Fondaparinux sodium impurity 4 Fondaparinux sodium impurity 4
Ampicillin Impurity W Ampicillin Impurity W
Lasmiditan Impurity 5 Lasmiditan Impurity 5
Olodaterol Impurity 18 Olodaterol Impurity 18 2727170-18-3
Febuxostat impurity DAC Febuxostat impurity DAC
ETHYL1-METHYL-2-OXOCYCLOPENTANECARBOXYLATE ETHYL1-METHYL-2-OXOCYCLOPENTANECARBOXYLATE 5453-88-3 C9H14O3
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