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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
AztreonaM IMpurity D AztreonaM IMpurity D
Busulfan IMpurity 1 Busulfan IMpurity 1 1797106-48-9 C6H14O5S2
Deferasirox Ethyl Ester Deferasirox Ethyl Ester 201530-79-2 C23H19N3O4
MetoclopraMide IMpurity F MetoclopraMide IMpurity F 38339-95-6 C13H20ClN3O2
Metronidazole IMpurity E Metronidazole IMpurity E
Propofol IMpurity H Propofol IMpurity H
R-(-)-O-DesMethyl-Venlafaxine-d6 R-(-)-O-DesMethyl-Venlafaxine-d6 1062609-96-4 C16H25NO2
Ribavirin IMp. C (EP) Ribavirin IMp. C (EP)
SalMeterol IMpurity B SalMeterol IMpurity B C25H37NO4
Sitagliptin N-Phoshate IMpurity Sitagliptin N-Phoshate IMpurity 1351498-25-3 C16H16F6N5O4P
SulbactaM IMpurity E SulbactaM IMpurity E
TriMethopriM IMpurity A TriMethopriM IMpurity A 213745-86-9 C15H20N4O3
Varenicline Metadinitro IMpurity Varenicline Metadinitro IMpurity
1-(4-methoxyphenyl)-2-methylpropan-2-amine 1-(4-methoxyphenyl)-2-methylpropan-2-amine 56490-94-9 C11H17NO
product/153101 product/153101
2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 877858-27-0 C12H12N2O
Apixaban IMpurity(BMS-778960-01) Apixaban IMpurity(BMS-778960-01)
1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 704916-12-1 C26H21FO7
2(1H)-Pyrazinone, 3-phenyl- 2(1H)-Pyrazinone, 3-phenyl- 2882-18-0 C10H8N2O
Oseltamivir Impurity 123 Oseltamivir Impurity 123
Oseltamivir Impurity 113 Oseltamivir Impurity 113
Avatrombopag Impurity 65 Avatrombopag Impurity 65
Apremilast Impurity 46 Apremilast Impurity 46
1H-Thieno[3,4-d]imidazole-4-valeric acid, hexahydro-2-oxo-, stereoisomer (8CI) 1H-Thieno[3,4-d]imidazole-4-valeric acid, hexahydro-2-oxo-, stereoisomer (8CI) 21788-37-4 C10H16N2O3S
pazufloxacin pazufloxacin 166665-94-7 C16H15FN2O4
MK 485 MK 485 28875-92-5 C10H14N2O4
1,3-Dioxane-4-aceticacid,6-(cyanomethyl)-2,2-dimethyl-,(4R,6R)-(9CI) 1,3-Dioxane-4-aceticacid,6-(cyanomethyl)-2,2-dimethyl-,(4R,6R)-(9CI) 807312-27-2 C10H15NO4
Esmolol Impurity 46 Esmolol Impurity 46
Chlorpheniramine Chlorpheniramine 78539-96-5 C16H19ClN2
9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 121869-35-0 C72H99N17O25
(1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine (1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine 38284-47-8 C17H31NO2
[4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone [4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone 105356-89-6 C18H23N5O4
2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 1330632-47-7 C22H24N2O5S2
2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 17289-54-2 C14H23ClN2O
3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 641571-16-6 C11H10F3N3
4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 1061214-09-2 C17H15F3N2O3S
5-(Ethoxycarbonyl)-2-(hydroxyMethyl-6-Methyl-4-(3-nitrophenyl)nicotinic Acid 5-(Ethoxycarbonyl)-2-(hydroxyMethyl-6-Methyl-4-(3-nitrophenyl)nicotinic Acid 89267-43-6 C17H16N2O7
9-L-β-Aspartic acid-daptoMycin 9-L-β-Aspartic acid-daptoMycin 123180-72-3 C72H101N17O26
Chlorhexidine Digluconate IMpurity K Chlorhexidine Digluconate IMpurity K 1381962-77-1 C22H29Cl2N9O
Cyclopropyl 3-Fluorobenzyl Ketone Cyclopropyl 3-Fluorobenzyl Ketone 952722-64-4 C11H11FO
Linear DaptoMycin Linear DaptoMycin 883991-21-7 C72H103N17O27
N,N-DiMethylaMidino) Urea N,N-DiMethylaMidino) Urea 98026-16-5 C4H10N4O
rac Dehydro-O-desMethyl Venlafaxine rac Dehydro-O-desMethyl Venlafaxine 1346600-38-1 C16H23NO
3-HYDROXY DESLORATADINE HCL 3-HYDROXY DESLORATADINE HCL 119410-08-1 C19H19ClN2O
2-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide 2-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide 1797905-42-0 C26H24FNO3
Atorvastatin Lactam Lactone Atorvastatin Lactam Lactone 1795791-15-9 C33H31FN2O5
Vinorelbine N'b-Oxide Sulfate Salt Vinorelbine N'b-Oxide Sulfate Salt 74075-34-6 C45H54N4O9
Linagliptin iMpurity G Linagliptin iMpurity G 668270-11-9 C25H28N8O2
Tadalafil EP IMpurity F Tadalafil EP IMpurity F
(2R,3R,4R,5S)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-fluoro-4-Methyltetrahydrofuran-3-yl benzoate (2R,3R,4R,5S)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-fluoro-4-Methyltetrahydrofuran-3-yl benzoate 874638-94-5 C31H26FN3O7
CefuroxiMe sodiuM iMpurity B CefuroxiMe sodiuM iMpurity B C16H16N4NaO8S
Fasudil N-hydroxy iMpurity Fasudil N-hydroxy iMpurity 1350827-92-7 C14H17N3O3S
TaMsulosin IMpurity A TaMsulosin IMpurity A C20H28N2O5S
1-((2'-cyanobiphenyl-4-yl)Methyl)-2-ethoxy-1H-benziMidazole-7-carboxylic acid 1-((2'-cyanobiphenyl-4-yl)Methyl)-2-ethoxy-1H-benziMidazole-7-carboxylic acid 632322-61-3 C24H19N3O3
5-Methoxy-2-Hydroxy Benzimidazole 5-Methoxy-2-Hydroxy Benzimidazole 208-75-3 C13H9N
SODIUM CAMPTOTHECIN SODIUM CAMPTOTHECIN 25387-67-1 C20H17N2NaO5
(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-L-cysteine (5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-L-cysteine 2238849-52-8 C13H15N3O3S
Doxylamine Impurity E Doxylamine Impurity E
Phenoxymethylpenicillin Potassium EP Impurity F Phenoxymethylpenicillin Potassium EP Impurity F 2714805-53-3 C15H20N2O4S
Methylprednisolone EP Impurity D1 Methylprednisolone EP Impurity D1
Nirmatrelvir Impurity 13 Nirmatrelvir Impurity 13
2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI) 2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI) 611226-36-9 C7H8N2O2
2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI) 2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI) 727375-13-5 C8H11NO2
Bumetanide Impurity 22 Bumetanide Impurity 22
Rocuronium Bromide Impurity 32 、33 Rocuronium Bromide Impurity 32 、33
Flucloxacillin Sodium Impurity X Flucloxacillin Sodium Impurity X
Pitavastatin Impurity 98 Pitavastatin Impurity 98
Perospirone Impurity 29 Perospirone Impurity 29
Perospirone Impurity 24 Perospirone Impurity 24
Perospirone Impurity 7 Perospirone Impurity 7 1002359-81-0
2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14- tetraen-1-yl)oxy)naphthalen-1-yl acetate 2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14- tetraen-1-yl)oxy)naphthalen-1-yl acetate
Paxlovid Impurity 17 Paxlovid Impurity 17
Related impurities of fluoxetine sodium 19 Related impurities of fluoxetine sodium 19
Fondaparinux sodium impurity 16 Fondaparinux sodium impurity 16
Fondaparinux Sodium Impurity 11 Fondaparinux Sodium Impurity 11
Oxacillin  Impurity E Oxacillin Impurity E
AZOBENZENE-3-CARBOXYLICACID AZOBENZENE-3-CARBOXYLICACID 14474-22-7 C13H10N2O2
Bosutinib Impurity 40 Bosutinib Impurity 40
Ticagrelor Impurity J&K Ticagrelor Impurity J&K
Olodaterol Impurity 24 Olodaterol Impurity 24
Miglitol Isomer ImpurityB Miglitol Isomer ImpurityB
benzhydryl (6R,7S)-7-(2-mercaptoacetamido)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate benzhydryl (6R,7S)-7-(2-mercaptoacetamido)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
43,50-Dicarboxy-cyanoco balamin 43,50-Dicarboxy-cyanoco balamin
(1R,4S) Sertraline Hydrochloride (1R,4S) Sertraline Hydrochloride 79896-32-5 C17H18Cl3N
4-Desmethoxy-4-chloro Omeprazole Sulfide 4-Desmethoxy-4-chloro Omeprazole Sulfide 220757-74-4 C16H16ClN3OS
N-Desmethyl Tamoxifen Hydrochloride N-Desmethyl Tamoxifen Hydrochloride 15917-65-4 C25H27NO.ClH
(3S,5S)-Atorvastatin sodium salt (3S,5S)-Atorvastatin sodium salt 501121-34-2 C33H35FN2O5
bromobenzarone bromobenzarone 94729-09-6 C17H13BrO3
Oprinone Impurity 3 Oprinone Impurity 3
digoxigenin-bis(digitoxoside) digoxigenin-bis(digitoxoside) 5297-05-2 C35H54O11
17 alpha-cyanomethyl-19-nortestosterone 17 alpha-cyanomethyl-19-nortestosterone 67473-36-3 C20H27NO2
desmethylazelastine desmethylazelastine 47491-38-3 C21H22ClN3O
8-hydroxyclomipramine 8-hydroxyclomipramine 83385-97-1 C19H23ClN2O
Ro 15-3505 Ro 15-3505 78756-33-9 C15H14ClN3O3
L 683519 L 683519 132172-14-6 C43H67NO12
benzylpenicilloic acid benzylpenicilloic acid 13057-98-2 C16H20N2O5S
erythralosamine erythralosamine 546-57-6 C29H49NO8
6-methylprednisone 6-methylprednisone 91523-05-6 C22H28O5
HYDROXYMETHYL CELECOXIB HYDROXYMETHYL CELECOXIB 170571-00-3 C17H14F3N3O3S
2-(2-cyanophenyl)benzonitrile 2-(2-cyanophenyl)benzonitrile 4341-02-0 C14H8N2
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