A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C103201 OPTICAL ACTIVITY A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C45997 pH A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C60821 Solubility A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C63394 Melting Point A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C64832 Specific Gravity A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C86573 Odor A FDA C133807 SPL PQ/CMC Test Category Terminology C25365 Description/Appearance A FDA C133807 SPL PQ/CMC Test Category Terminology C25737 Identification A FDA C133807 SPL PQ/CMC Test Category Terminology C60819 Assay (chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio) A FDA C133807 SPL PQ/CMC Test Category Terminology C61365 Homogeneity Test A FDA C133846 SPL PQ/CMC Batch Utilization Terminology C133990 Commercial A FDA C133846 SPL PQ/CMC Batch Utilization Terminology C133991 Development A FDA C133846 SPL PQ/CMC Batch Utilization Terminology C133992 Clinical A FDA C133846 SPL PQ/CMC Batch Utilization Terminology C133993 Validation A FDA C133846 SPL PQ/CMC Batch Utilization Terminology C133994 Bioequivalence A FDA C133847 SPL PQ/CMC Chemical Structure Data File Origin Terminology C133995 Experimental A FDA C133847 SPL PQ/CMC Chemical Structure Data File Origin Terminology C16275 Calculated A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C133910 MOLFILE A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C133996 SDF A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C133997 mmCIF (large molecules) A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C49039 PDB A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C54683 InChI File (small molecule) A FDA C133848 SPL PQ/CMC Chemical Structure Data File Type Terminology C54684 SMILES A FDA C133849 SPL PQ/CMC Closure Type Terminology C96113 Child-resistant, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96114 Child-resistant, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96115 Continuous Thread, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96116 Continuous Thread, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96117 Tamper-evident, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96118 Tamper-evident, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96119 Vacuum, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96120 Tamper-evident, Composite A FDA C133849 SPL PQ/CMC Closure Type Terminology C96121 Vacuum, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96122 Vacuum, Composite A FDA C133849 SPL PQ/CMC Closure Type Terminology C96123 Press-on/twist-off, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96124 Press-on, Composite A FDA C133849 SPL PQ/CMC Closure Type Terminology C96125 Crown, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96126 Lug, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96127 Roll-on, Metal A FDA C133849 SPL PQ/CMC Closure Type Terminology C96128 Flip-Top (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96129 Hinged (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96130 Linerless, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96131 Pump (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96132 Push-pull (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96133 Snap-on Cap, Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96134 Snip-tip (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96135 Toggle-swing (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96136 Trigger Sprayer (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96137 Twist Open/Close (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96138 Valved (Dispensing), Plastic A FDA C133849 SPL PQ/CMC Closure Type Terminology C96139 Stopper A FDA C133849 SPL PQ/CMC Closure Type Terminology C96140 Tie A FDA C133850 SPL PQ/CMC Compendial Method Verification Indicator Terminology C49487 No A FDA C133850 SPL PQ/CMC Compendial Method Verification Indicator Terminology C49488 Yes A FDA C133851 SPL PQ/CMC Conformance to Criteria Terminology C133998 Does not conform A FDA C133851 SPL PQ/CMC Conformance to Criteria Terminology C80262 Conforms A FDA C133852 SPL PQ/CMC Container Orientation Terminology C133914 Valve-up A FDA C133852 SPL PQ/CMC Container Orientation Terminology C133915 Valve-down A FDA C133852 SPL PQ/CMC Container Orientation Terminology C133999 Inverted A FDA C133852 SPL PQ/CMC Container Orientation Terminology C25241 Horizontal A FDA C133852 SPL PQ/CMC Container Orientation Terminology C86043 Upright A FDA C133853 SPL PQ/CMC Container Type Terminology C16738 INHALER A FDA C133853 SPL PQ/CMC Container Type Terminology C42794 TUBE A FDA C133853 SPL PQ/CMC Container Type Terminology C43165 AMPULE A FDA C133853 SPL PQ/CMC Container Type Terminology C43166 APPLICATOR A FDA C133853 SPL PQ/CMC Container Type Terminology C43167 BAG A FDA C133853 SPL PQ/CMC Container Type Terminology C43168 BLISTER PACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43169 BOTTLE A FDA C133853 SPL PQ/CMC Container Type Terminology C43170 BOTTLE, DISPENSING A FDA C133853 SPL PQ/CMC Container Type Terminology C43171 BOTTLE, DROPPER A FDA C133853 SPL PQ/CMC Container Type Terminology C43172 BOTTLE, GLASS A FDA C133853 SPL PQ/CMC Container Type Terminology C43173 BOTTLE, PLASTIC A FDA C133853 SPL PQ/CMC Container Type Terminology C43174 BOTTLE, PUMP A FDA C133853 SPL PQ/CMC Container Type Terminology C43175 BOTTLE, SPRAY A FDA C133853 SPL PQ/CMC Container Type Terminology C43176 BOTTLE, UNIT-DOSE A FDA C133853 SPL PQ/CMC Container Type Terminology C43177 BOTTLE, WITH APPLICATOR A FDA C133853 SPL PQ/CMC Container Type Terminology C43178 BOX A FDA C133853 SPL PQ/CMC Container Type Terminology C43179 Box, Unit-Dose|BOX, UNIT-DOSE A FDA C133853 SPL PQ/CMC Container Type Terminology C43180 CAN A FDA C133853 SPL PQ/CMC Container Type Terminology C43181 CANISTER A FDA C133853 SPL PQ/CMC Container Type Terminology C43182 CARTON A FDA C133853 SPL PQ/CMC Container Type Terminology C43183 CARTRIDGE A FDA C133853 SPL PQ/CMC Container Type Terminology C43184 CASE A FDA C133853 SPL PQ/CMC Container Type Terminology C43185 CELLO PACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43186 CONTAINER A FDA C133853 SPL PQ/CMC Container Type Terminology C43187 CUP A FDA C133853 SPL PQ/CMC Container Type Terminology C43188 CUP, UNIT-DOSE A FDA C133853 SPL PQ/CMC Container Type Terminology C43189 CYLINDER A FDA C133853 SPL PQ/CMC Container Type Terminology C43190 DEWAR A FDA C133853 SPL PQ/CMC Container Type Terminology C43191 DIALPACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43192 DOSE PACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43193 DRUM A FDA C133853 SPL PQ/CMC Container Type Terminology C43194 INHALER, REFILL A FDA C133853 SPL PQ/CMC Container Type Terminology C43195 JAR A FDA C133853 SPL PQ/CMC Container Type Terminology C43196 JUG A FDA C133853 SPL PQ/CMC Container Type Terminology C43197 KIT A FDA C133853 SPL PQ/CMC Container Type Terminology C43198 PACKAGE, COMBINATION A FDA C133853 SPL PQ/CMC Container Type Terminology C43199 PACKET A FDA C133853 SPL PQ/CMC Container Type Terminology C43200 POUCH A FDA C133853 SPL PQ/CMC Container Type Terminology C43201 SUPERSACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43202 SYRINGE A FDA C133853 SPL PQ/CMC Container Type Terminology C43203 SYRINGE, GLASS A FDA C133853 SPL PQ/CMC Container Type Terminology C43204 SYRINGE, PLASTIC A FDA C133853 SPL PQ/CMC Container Type Terminology C43205 TABMINDER A FDA C133853 SPL PQ/CMC Container Type Terminology C43206 TANK A FDA C133853 SPL PQ/CMC Container Type Terminology C43207 TUBE, WITH APPLICATOR A FDA C133853 SPL PQ/CMC Container Type Terminology C43208 VIAL, DISPENSING A FDA C133853 SPL PQ/CMC Container Type Terminology C43209 VIAL, GLASS A FDA C133853 SPL PQ/CMC Container Type Terminology C43210 VIAL, MULTI-DOSE A FDA C133853 SPL PQ/CMC Container Type Terminology C43211 VIAL, PATENT DELIVERY SYSTEM A FDA C133853 SPL PQ/CMC Container Type Terminology C43212 VIAL, PHARMACY BULK PACKAGE A FDA C133853 SPL PQ/CMC Container Type Terminology C43213 VIAL, PIGGYBACK A FDA C133853 SPL PQ/CMC Container Type Terminology C43214 VIAL, PLASTIC A FDA C133853 SPL PQ/CMC Container Type Terminology C43215 VIAL, SINGLE-DOSE A FDA C133853 SPL PQ/CMC Container Type Terminology C43216 VIAL, SINGLE-USE A FDA C133853 SPL PQ/CMC Container Type Terminology C43226 VIAL A FDA C133853 SPL PQ/CMC Container Type Terminology C43233 PACKAGE A FDA C133853 SPL PQ/CMC Container Type Terminology C48626 NOT STATED A FDA C133853 SPL PQ/CMC Container Type Terminology C53438 TRAY A FDA C133853 SPL PQ/CMC Container Type Terminology C79135 FLEXIBLE INTERMEDIATE BULK CONTAINER A FDA C133853 SPL PQ/CMC Container Type Terminology C79136 PAIL A FDA C133853 SPL PQ/CMC Container Type Terminology C82332 PATCH A FDA C133853 SPL PQ/CMC Container Type Terminology C92708 CAPSULE A FDA C133853 SPL PQ/CMC Container Type Terminology C96141 Dish, Petri A FDA C133853 SPL PQ/CMC Container Type Terminology C96142 Plate, Microwell A FDA C133853 SPL PQ/CMC Container Type Terminology C96143 Canisters, lined A FDA C133853 SPL PQ/CMC Container Type Terminology C96144 Flask A FDA C133855 SPL PQ/CMC Drug Substance Product Indicator Terminology C1909 Product A FDA C133855 SPL PQ/CMC Drug Substance Product Indicator Terminology C45306 SUBSTANCE A FDA C133856 SPL PQ/CMC Impurity Classification Terminology C134000 Organic Impurities (process- and product-related) A FDA C133856 SPL PQ/CMC Impurity Classification Terminology C134001 Inorganic Impurities A FDA C133857 SPL PQ/CMC Interpretation Code (text) Terminology C44281 Failed A FDA C133857 SPL PQ/CMC Interpretation Code (text) Terminology C48660 NA A FDA C133857 SPL PQ/CMC Interpretation Code (text) Terminology C81275 Passed A FDA C133858 SPL PQ/CMC Interpretation Code (numeric) Terminology C48660 NA A FDA C133858 SPL PQ/CMC Interpretation Code (numeric) Terminology C61583 NLT (not less than) A FDA C133858 SPL PQ/CMC Interpretation Code (numeric) Terminology C61584 MT (more than) A FDA C133858 SPL PQ/CMC Interpretation Code (numeric) Terminology C61585 LT (less than) A FDA C133858 SPL PQ/CMC Interpretation Code (numeric) Terminology C61586 NMT (not more than) A FDA C133859 SPL PQ/CMC Manufacturing Site Unique Identifier Terminology C134003 DUNS A FDA C133859 SPL PQ/CMC Manufacturing Site Unique Identifier Terminology C134004 FEI A FDA C133859 SPL PQ/CMC Manufacturing Site Unique Identifier Terminology C134005 CFN A FDA C133859 SPL PQ/CMC Manufacturing Site Unique Identifier Terminology C17998 Unknown A FDA C133860 SPL PQ/CMC Quality Benchmark Terminology C134006 USP-NF A FDA C133860 SPL PQ/CMC Quality Benchmark Terminology C134007 EP A FDA C133860 SPL PQ/CMC Quality Benchmark Terminology C134008 JP A FDA C133860 SPL PQ/CMC Quality Benchmark Terminology C134009 Company Standard A FDA C133862 SPL PQ/CMC Source Type Terminology C14182 Animal A FDA C133862 SPL PQ/CMC Source Type Terminology C14225 Human A FDA C133862 SPL PQ/CMC Source Type Terminology C14227 Insect A FDA C133862 SPL PQ/CMC Source Type Terminology C14258 Plant A FDA C133862 SPL PQ/CMC Source Type Terminology C14329 Microbial A FDA C133862 SPL PQ/CMC Source Type Terminology C18634 Animal-derived indirectly A FDA C133862 SPL PQ/CMC Source Type Terminology C48807 Chemical A FDA C133863 SPL PQ/CMC Specification Status Terminology C134010 Tentatively Approved A FDA C133863 SPL PQ/CMC Specification Status Terminology C134011 Not Approved A FDA C133863 SPL PQ/CMC Specification Status Terminology C134012 Reported in a CBE or AR A FDA C133863 SPL PQ/CMC Specification Status Terminology C25425 Approved A FDA C133864 SPL PQ/CMC Specification Type Terminology C133931 Raw Materials/Excipients/Intermediates/Reagents A FDA C133864 SPL PQ/CMC Specification Type Terminology C134021 Drug Product A FDA C133864 SPL PQ/CMC Specification Type Terminology C134022 Drug Substance A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C133935 5 +/- 3 degrees C A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C133936 -20 +/- 5 degrees C A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C133940 40 degrees C +/- 2 degrees C/not more than (NMT) 25% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134014 25 +/- 2 degrees C /60% +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134015 30 +/- 2 degrees C /65% +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134016 40 +/- 2 degrees C /75% +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134017 30 +/- 2 degrees C /75% +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134018 25 +/- 2 degrees C /40% +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C134019 30 degrees C +/- 2 degrees C/35% RH +/- 5% RH A FDA C133865 SPL PQ/CMC Storage Conditions Terminology C96148 Proprietary A FDA C133866 SPL PQ/CMC Study Type Terminology C134026 Standard A FDA C133866 SPL PQ/CMC Study Type Terminology C134027 Cycled-Simple A FDA C133866 SPL PQ/CMC Study Type Terminology C134028 Complex A FDA C133867 SPL PQ/CMC Test Method Origin Terminology C96102 Compendial A FDA C133867 SPL PQ/CMC Test Method Origin Terminology C96103 Proprietary A FDA C133867 SPL PQ/CMC Test Method Origin Terminology C96164 CFR A FDA C133868 SPL PQ/CMC Test Usage Terminology C134029 Release A FDA C133868 SPL PQ/CMC Test Usage Terminology C134030 Stability A FDA C133868 SPL PQ/CMC Test Usage Terminology C134031 Release and Stability A FDA C133869 SPL PQ/CMC Testing Site Unique Identifier Terminology C134003 DUNS A FDA C133869 SPL PQ/CMC Testing Site Unique Identifier Terminology C134004 FEI A FDA C133869 SPL PQ/CMC Testing Site Unique Identifier Terminology C134005 CFN A FDA C133869 SPL PQ/CMC Testing Site Unique Identifier Terminology C17998 Unknown A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134032 Specificity A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134033 Linearity A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134240 Range A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134242 Accuracy A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134243 Precision A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134244 Detection Limit A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134245 Robustness A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134246 System Suitability A FDA C133870 SPL PQ/CMC Validation Parameter Terminology C134248 Quantitation Limit A FDA C133806 SPL PQ/CMC Physicochemical Properties Terminology C134259 Physicochemical Properties