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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
1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 161771-76-2 C9H10N2O3S
(Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate (Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate 881995-70-6 C11H10F3NO2
6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 926319-53-1 C17H14BrNO4
(2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid (2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid C26H31N2O5
2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid
(Diketopiperazine) 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine) C29H42N8O18S4
Methoxyvinpocetine Methoxyvinpocetine
rac Des(isopropylaMino) Acebutolol Diol rac Des(isopropylaMino) Acebutolol Diol 96480-91-0 C15H21NO5
(17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile (17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile 106111-42-6 C20H25NO2
(3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine (3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine 177793-80-5 C18H26N2
4-(4-Fluorophenyl)-1-Methyl- 4-(4-Fluorophenyl)-1-Methyl- 1012886-75-7 C12H15ClFN
5'(S)-Hydroxy SiMvastatin  DISCONTINUED 5'(S)-Hydroxy SiMvastatin DISCONTINUED 149949-05-3 C25H38O6
5'-Epi-LaMivudine 5'-Epi-LaMivudine 136846-20-3 C8H11N3O3S
N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) 686299-20-7 C8H14N4O6
SiMvastatin 4'-Methyl Ether SiMvastatin 4'-Methyl Ether 864357-88-0 C26H40O5
(2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane (2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane 162849-95-8 C28H35N3O5S
1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 885340-11-4 C32H34F3N3O4
4-DesMethoxy-4-broMo TriMethopriM 4-DesMethoxy-4-broMo TriMethopriM 16285-82-8 C13H15BrN4O2
Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate 82398-34-3 C12H24N5O5Pt2+
3-Bromo-5-chloropyrazine-2-carbonitrile 3-Bromo-5-chloropyrazine-2-carbonitrile 440124-25-4 C5HBrClN3
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
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
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
(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
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
Aids004544 Aids004544 145397-25-7 C8H10FN3O4
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-(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
Tigecycline Impurity 6 Tigecycline Impurity 6
Febuxostat Bromo Impurity Febuxostat Bromo Impurity 144060-40-2 C15H16BrNO3S
Meptazinol Impurity Meptazinol Impurity 1314003-47-8 C23H28N2O4
1'H-2,3'-bipyridinyl-2'-one 1'H-2,3'-bipyridinyl-2'-one 101002-01-1 C10H8N2O
Brexpiprazole Impurity D Brexpiprazole Impurity D
Brivaracetam Impurity E Brivaracetam Impurity E
Dapoxetine Impurity 8 Dapoxetine Impurity 8
Irbesartan Impurity 6 Irbesartan Impurity 6 C25H28N6O
Empagliflozin impurity B Empagliflozin impurity B
Varenicline Impurity 1 Varenicline Impurity 1
Voriconazole Impurity 6 Voriconazole Impurity 6
Caspofungin impurity 1 Caspofungin impurity 1
Cabozantinib impurity D Cabozantinib impurity D
Neratinib Impurity 3 Neratinib Impurity 3
Ranitidine Impurity D Ranitidine Impurity D C13H22N4O3S
Metoprolol IMpurity 5 Metoprolol IMpurity 5 C15H25NO3
Mirabegron Impurity 2 Mirabegron Impurity 2
Pemetrexed Impurity 1 Pemetrexed Impurity 1 1644287-26-2 C20H21N5O8
Plerixafor Impurity B Plerixafor Impurity B
Tolvaptan impurity3 Tolvaptan impurity3
Vonoprazan Impurity 7 Vonoprazan Impurity 7
Cefazolin impurity F Cefazolin impurity F
Apremilast Impurity 3 Apremilast Impurity 3 88687-92-7 C16H10N2O8
Apixaban Impurity 8 Apixaban Impurity 8 1777781-49-3 C24H23N5O4
Ritodrine BP Impurity D Ritodrine BP Impurity D
Rivaroxaban Impurity 19 Rivaroxaban Impurity 19
Topiroxostat Impurity 4 Topiroxostat Impurity 4 1379342-46-7 C8H8N2O3
Ertapenem impurity 1 Ertapenem impurity 1
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate C26H36NO3
Flomoxef Impurity 3 Flomoxef Impurity 3
Ropivacaine impurity Ropivacaine impurity 1105704-96-8 C12H14N2O3
Agomelatine Impurity 1 Agomelatine Impurity 1 1352139-51-5 C15H19NO2
Diquafosol Impurity 1 Diquafosol Impurity 1 26184-65-6 C18H24N4O17P2
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