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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
Tenofovir Related Compound 10 Tenofovir Related Compound 10 16958-60-4 C8H11N5O
N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide C31H33N7O2
N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine C24H23N5
(E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid (E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid C21H18FN3O5S
Apremilast Apremilast 1384439-80-8 C17H16N2O6S
TROXACITABINE TROXACITABINE 145511-98-4 C8H11N3O4
XXZJUZXKBFUPQH-IKGGRYGDSA-N XXZJUZXKBFUPQH-IKGGRYGDSA-N 1618657-31-0 C18H17FO4
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
Topiroxostat Impurity 2 Topiroxostat Impurity 2 445218-61-1 C12H11N5O
Fluvastatin Impurity 1 Fluvastatin Impurity 1 C24H26FNO4
Lornoxicam Impurity 7 Lornoxicam Impurity 7
Prednisolone Impurity A Prednisolone Impurity A C21H28O5
Tofacitinib Impurity 6 Tofacitinib Impurity 6 1640972-35-5 C16H22N6O
Afatinib Impurity 20 Afatinib Impurity 20
1-(4-Ethylphenyl)-2-methyl-2-propen-1-one 1-(4-Ethylphenyl)-2-methyl-2-propen-1-one 70639-76-8 C12H14O
Ceftriaxone Sodium impurity Ceftriaxone Sodium impurity
Clarithromycin impurity Clarithromycin impurity
Ivabradine Impurity 5 Ivabradine Impurity 5 1462470-54-7 C27H38N2O6
Aprepitant Impurity 6 Aprepitant Impurity 6 170902-81-5 C23H21F7N4O3
(S)-3-((R)-5-(4-fluorophenyl)-5-hydroxy-2-((E)-4-hydroxybenzylidene)pentanoyl)-4-phenyloxazolidin-2-one (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxy-2-((E)-4-hydroxybenzylidene)pentanoyl)-4-phenyloxazolidin-2-one C27H24FNO5
Alogliptin Related Compound 14 Alogliptin Related Compound 14 1820685-30-0 C18H23N5O3
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
(3S,5S)-Atorvastatin (sodium salt) (3S,5S)-Atorvastatin (sodium salt) 1428118-38-0 C33H36FN2NaO5
Chlorpromazine EP impurity B Chlorpromazine EP impurity B 19077-20-4 C21H28ClN3S
2-amino-4-fluoro-5-nitrobenzoic acid 2-amino-4-fluoro-5-nitrobenzoic acid 1194097-41-0 C7H5FN2O4
Alogliptin benzoate impurity K Alogliptin benzoate impurity K 1618644-32-8 C25H25N5O3
Belinostat Z-isomer Belinostat Z-isomer 1884227-58-0 C15H14N2O4S
Canagliflozin Impurity 13 Canagliflozin Impurity 13
Carfilzomib Impurity 1 Carfilzomib Impurity 1
Dapagliflozin Impurity 14 Dapagliflozin Impurity 14 2271248-78-1 C21H25ClO6
Ibrutinib Impurity 13 Ibrutinib Impurity 13
Linagliptin Impurity 26 Linagliptin Impurity 26 2446799-71-7 C20H17BrN6O2
Nintedanib Impurity 13 (Intedanib Impurity 13) Nintedanib Impurity 13 (Intedanib Impurity 13)
vildagliptin Impurity E vildagliptin Impurity E 1789703-37-2 C17H25N3O2
Sitagliptin Impurity 1 Sitagliptin Impurity 1 823817-55-6 C16H15F6N5O
Niraparib metabolite M1 Niraparib metabolite M1 1476777-06-6 C19H19N3O2
Amlodipine Impurity 16 Amlodipine Impurity 16 C26H31ClN2O8S
Edoxaban Impurity 11 (1R,2R,4S) Edoxaban Impurity 11 (1R,2R,4S) 480451-98-7 C21H30ClN5O5
Rivaroxaban Impurity 25 Rivaroxaban Impurity 25 931117-61-2 C19H21Cl2N3O6S
(R)-CITALOPRAM                              R-(+)-1-3-(dimethyl-amino) propyl-1-(p-fluorophenyl)-5-phthalancarbonitrile (R)-CITALOPRAM R-(+)-1-3-(dimethyl-amino) propyl-1-(p-fluorophenyl)-5-phthalancarbonitrile
Atorvastatin pyrrolidone lactone Atorvastatin pyrrolidone lactone 906552-19-0 C33H33FN2O5
Cabozantinib Impurity G Cabozantinib Impurity G
Clopidogrel Impurity 10 Clopidogrel Impurity 10 C15H14ClNO2S
Dapoxetine Impurity 4 HCl Dapoxetine Impurity 4 HCl 119357-39-0 C21H23NO
Medetomidine Impurity 2 Medetomidine Impurity 2 33967-19-0 C10H14O
Tofacitinib Impurity 34 Tofacitinib Impurity 34 2459302-86-2 C19H22N8
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